FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM
K Number: K874663
·
Decision May 31, 1988
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
2
Review Days
200
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Basic Information
- Device Name
- MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM
- K Number
- K874663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ametek/Thermox Instruments Division
- Date Received
- November 13, 1987
- Decision Date
- May 31, 1988
- 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 |
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Other Clearances by Ametek/Thermox Instruments Division
| K Number | Device Name | ||
|---|---|---|---|
| K875183 | LC OXYGEN ANALYZER | Mar 29, 1988 | Substantially Equivalent |