FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RECON 1
K Number: K812128
·
Decision Aug 18, 1981
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
23
Applicant Total
2
Review Days
22
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
- RECON 1
- K Number
- K812128
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Precision Metering, Inc.
- Date Received
- July 27, 1981
- Decision Date
- August 18, 1981
- Product Code
- CAX
- 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 |
|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAX), ordered by most recent decision date.
MXR-2000 FLOWMETER
FDA 510(k)
FDA Class 1
·Anesthesiology
OHMEDA - LOW FLOW FLOWMETER
FDA 510(k)
FDA Class 1
·Anesthesiology
FR6000 FLOWMETER
FDA 510(k)
FDA Class 1
·Anesthesiology
SERIES D FLOWMETER
FDA 510(k)
FDA Class 1
·Anesthesiology
CLASSIC (TM) 200 OXYGEN FLOWMETER
FDA 510(k)
FDA Class 1
·Anesthesiology
AIRCO 2000 SERIES FLOWMETERS
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Precision Metering, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834260 | RECON-2 FLOW CONTROLLER | Jan 10, 1984 | Substantially Equivalent |