510(k) K022297
K022297 is an FDA 510(k) premarket notification submitted by Cardiocomm Solutions, Inc. for the device "GLOBAL ECG MANAGEMENT SYSTEM (GEMS)". The FDA issued a decision of Substantially Equivalent on Sep 27, 2002. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Cardiocomm Solutions, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 27, 2002
- Date Received
- Jul 16, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type
- 510(k)