Observer * Central Station
FDA 510(k) K972498 · Johnson & Johnson Medical, Inc.
510(k) numberK972498
Submission
- Device name
- Observer * Central Station
- Applicant
- Johnson & Johnson Medical, Inc.
Tampa, FL, US - Received
- July 3, 1997
- Decision date
- February 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was Observer * Central Station cleared by the FDA?
Observer * Central Station (K972498) received a 510(k) decision of Substantially Equivalent on February 17, 1998, 229 days after the submission was received.
What is the product code of K972498?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.