Welch Allyn H12+ 12-Lead Holter

देश: सिंगापुर

भाषा: अंग्रेज़ी

स्रोत: HSA (Health Sciences Authority)

थमां उपलब्ध:

Welch Allyn Singapore Pte. Ltd.

वर्ग:

Class B medical device

द्वारा बनाया गया:

Welch Allyn, Inc.

चिकित्सीय क्षेत्र:

Cardiovascular

चिकित्सीय संकेत:

The H12+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the H12+ recorder and are undergoing Holter monitoring. The H12+ acquires, digitizes and stores data to be analyzed by the HScribe Holter system. The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 48 hours. The H12+ does not perform cardiac analysis by itself and is intended to be used with the HScribe™ Holter analysis system. ECG data pre-recorded by the H12+ is acquired and analyzed by the HScribe Holter analysis system.

उत्पाद समीक्षा:

Device System Info:[Device with measuring function], [System or Procedure Pack]; Models: HS6 KIT SVR NTERFACE - HSCRIBE-6AC-CXXXC, HS6 KIT PDF DICOM - HSCRIBE-6AC-CXXXB, HS6 KIT PDF XML - HSCRIBE-6AC-CXXXA, HS6 SYS NOCONNECT - HSCRIBE-6AB-CXXXX, HS6 KIT NOCONNECT - HSCRIBE-6AC-CXXXX, PAT CBL 10WIRE LEADFORM AHA SNAP - 9293-017-50, PAT CBL 10WIRE LEADFORM IEC SNAP - 9293-017-51, PAT CBL 10WIRE LEADFORM XL AHA SNAP - 9293-026-50, PAT CBL 10WIRE LEADFORM XL IEC SNAP - 9293-026-51, PAT CBL 6WIRE AHA SNAP - 9293-028-50, PAT CBL 6WIRE IEC SNAP - 9293-028-51, H12PLUS 48H STD-SDMULTLANG AHA 0 - H12PLUS-MPA-XXXXX, H12PLUS 48H STD-SDMULTLANG AHA 0 - H12PLUS-MPC-XXXXX, H12PLUS 48H HF-SDMULTLANG AHA 0 - H12PLUS-OPA-XXXXX, H12PLUS 48H HF-SDMULTLANG AHA 0 - H12PLUS-OPC-XXXXX

प्राधिकरण की तारीख:

2021-11-03