FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MRM-2 OXYGEN CONSUMPTION MONITOR
K Number: K801852
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
16
Review Days
16
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
- MRM-2 OXYGEN CONSUMPTION MONITOR
- K Number
- K801852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Waters Assoc., Inc.
- Date Received
- August 4, 1980
- Decision Date
- August 20, 1980
- 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
Other Clearances by Waters Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K811975 | MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL | Jul 27, 1981 | Substantially Equivalent |
| K802481 | 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH | Oct 31, 1980 | Substantially Equivalent |
| K801431 | PAN-AM MYELOGRAM TRAY | Aug 12, 1980 | Substantially Equivalent |
| K791661 | SYSTEM CONTROLLER 720 SERIES | Sep 24, 1979 | Substantially Equivalent |
| K791026 | 4F STERILE BALLOON-LESS, CATHETER 913-28 | Jun 22, 1979 | Substantially Equivalent |
| K782175 | CARTRIDGE HOLDER, RCM 100 | Feb 15, 1979 | Substantially Equivalent |
| K790145 | SOLVENT DELIVERY SYSTEM | Feb 15, 1979 | Substantially Equivalent |
| K781805 | CARDIAC COMPUTERS, CO-10 & CO-10R | Jan 29, 1979 | Substantially Equivalent |
| K781915 | DATA MODULE | Jan 10, 1979 | Substantially Equivalent |
| K781692 | CALIBRATOR, DYNAMIC | Nov 29, 1978 | Substantially Equivalent |