510(k) K972498
K972498 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "OBSERVER * CENTRAL STATION". The FDA issued a decision of Substantially Equivalent on February 17, 1998. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1998
- Date Received
- July 3, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type