Infinity Multiview Infinity Telemetry System
FDA 510(k) K033305 · Draeger Medical Systems, Inc.
510(k) numberK033305
Submission
- Device name
- Infinity Multiview Infinity Telemetry System
- Applicant
- Draeger Medical Systems, Inc.
Danvers, MA, US - Received
- October 14, 2003
- Decision date
- October 31, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
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Questions and answers
When was Infinity Multiview Infinity Telemetry System cleared by the FDA?
Infinity Multiview Infinity Telemetry System (K033305) received a 510(k) decision of Substantially Equivalent on October 31, 2003, 17 days after the submission was received.
What is the product code of K033305?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.