FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
OXYLOG 2
K Number: K954731
·
Decision Jan 6, 1997
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
4
Review Days
448
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OXYLOG 2
- K Number
- K954731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- P.K. Morgan , Ltd.
- Date Received
- October 16, 1995
- Decision Date
- January 6, 1997
- Product Code
- BZL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZL | Computer, Oxygen-Uptake | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZL), ordered by most recent decision date.
Breezing Med
FDA 510(k)
FDA Class 2
·Anesthesiology
NICU V'02
FDA 510(k)
FDA Class 2
·Anesthesiology
ANASCIENT BREATH MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
METAPHOR METABOLIC MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
FITMATE SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
EXPRESS SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology