FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
K Number: K001775
·
Decision Jan 12, 2001
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
334
Applicant Total
4
Review Days
214
Basic Information
- Device Name
- ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
- K Number
- K001775
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZOE MEDICAL, INC.
- Date Received
- June 12, 2000
- Decision Date
- January 12, 2001
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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