510(k) K001775
K001775 is an FDA 510(k) premarket notification submitted by Zoe Medical, Inc. for the device "ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 12, 2001. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Zoe Medical, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 12, 2001
- Date Received
- Jun 12, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)