BXP · Transducer, Gas Flow
Anesthesiology · 21 CFR 868.2885 · Class 1
Overview
| Product Code | BXP |
|---|---|
| Device Name | Transducer, Gas Flow |
| Regulation | 21 CFR 868.2885 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A gas flow transducer is a device intended for medical purposes that is used to convert gas flow rate into an electrical signal for subsequent display or processing.
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 (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K936141 | UNIPOWER RECHARGEABLE BATTERY PACK | Unipower Corp. | Mar 31, 1994 | SESE |
| K920360 | TIMOX OXYGEN TIMER | Medical Fittings, Inc. | Aug 3, 1992 | SESE |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | Kells Medical, Inc. | Mar 7, 1984 | SESE |
| K800087 | ULTRASONIC FLOWMETER | The Perkin-Elmer Corp. | Mar 19, 1980 | SESE |
| K781039 | OXY-ON DIGITAL OXYGEN TIMER | Chambers & Sadler Mfg. | Aug 31, 1978 | SESE |
| K770424 | OXYGEN TWMER, MODEL SST | Timeter Instrument Corp. | Mar 16, 1977 | SESE |
| K761260 | ARIZONA OXYGEN TIMER DEVICE | The John Bunn Co. | Dec 16, 1976 | SESE |
Top Applicants
- Unipower Corp. — 1 clearance
- Timeter Instrument Corp. — 1 clearance
- The Perkin-Elmer Corp. — 1 clearance
- The John Bunn Co. — 1 clearance
- Medical Fittings, Inc. — 1 clearance
