CAX · Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Anesthesiology · 21 CFR 868.2340 · Class 1
Overview
| Product Code | CAX |
|---|---|
| Device Name | Flowmeter, Tube, Thorpe, Back-Pressure Compensated |
| Regulation | 21 CFR 868.2340 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (24)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K923781 | MXR-2000 FLOWMETER | Porter Instrument Co., Inc. | Jun 10, 1993 | SESE |
| K910316 | OHMEDA - LOW FLOW FLOWMETER | Ohmeda Medical | Apr 12, 1991 | SESE |
| K884973 | FR6000 FLOWMETER | Key Instruments | Jan 17, 1989 | SESE |
| K872718 | SERIES D FLOWMETER | Puritan Bennett Corp. | Aug 5, 1987 | SESE |
| K871452 | CLASSIC (TM) 200 OXYGEN FLOWMETER | The Timeter Group | Jun 22, 1987 | SESE |
| K862797 | AIRCO 2000 SERIES FLOWMETERS | Airco, Inc. | Aug 8, 1986 | SESE |
| K854067 | SELECT FLOWMETER | Precision Medical, Inc. | Oct 29, 1985 | SESE |
| K851288 | OXYGEN DELIVERY MEASURING DEVICE | Bar-Dix, Inc. | Sep 3, 1985 | SESE |
| K850559 | PRESSURE RELIEF ADAPTOR | Precision Medical, Inc. | Apr 25, 1985 | SESE |
| K850560 | FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE | Precision Medical, Inc. | Apr 17, 1985 | SESE |
| K834260 | RECON-2 FLOW CONTROLLER | Precision Metering, Inc. | Jan 10, 1984 | SESE |
| K812419 | PRESET FLOWMETER | Timeter Instrument Corp. | Sep 21, 1981 | SESE |
| K812183 | TIMETER-PRODUCED PURITAN BENNETT AIR ADP | Timeter Instrument Corp. | Aug 18, 1981 | SESE |
| K812128 | RECON 1 | Precision Metering, Inc. | Aug 18, 1981 | SESE |
| K802659 | RESPIRATORY THERAPY FLOWMETER | Design & Manufacturing Consultants | Nov 12, 1980 | SESE |
| K802311 | MO8 OXYGEN FLOWMETER | Timeter Instrument Corp. | Oct 23, 1980 | SESE |
| K791900 | M015 OXYGEN & MA15 AIR | Timeter Instrument Corp. | Oct 11, 1979 | SESE |
| K791648 | MODEL 54 FLOWMETER BACK-PRESSURE TUBE | Harris Calorific | Sep 17, 1979 | SESE |
| K791220 | FLOWMETER, BACK PRESSURE COMPENSATED, | Timeter Instrument Corp. | Aug 3, 1979 | SESE |
| K791017 | FLOW LIMITER | Timeter Instrument Corp. | Jul 3, 1979 | SESE |
| K791069 | LINDE OXYGEN THERAPY FLOWMETERS, L33-L34 | Union Carbide Corp. | Jun 27, 1979 | SESE |
| K781541 | FLOMETER | Chemetron Medical Products, Inc. | Sep 26, 1978 | SESE |
| K760314 | FLOWMETER, OXYGEN | Harris-Lake, Inc. | Aug 4, 1976 | SESE |
| K760102 | FLOWMETER, P.C., REDESIGNED VERSION | Ohio Medical Products | Jul 16, 1976 | SESE |
Top Applicants
- Timeter Instrument Corp. — 6 clearances
- Precision Medical, Inc. — 3 clearances
- Precision Metering, Inc. — 2 clearances
- Union Carbide Corp. — 1 clearance
- The Timeter Group — 1 clearance
