CCN · Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Anesthesiology · 21 CFR 868.2300 · Class 1
Overview
| Product Code | CCN |
|---|---|
| Device Name | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge |
| Regulation | 21 CFR 868.2300 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.
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 (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934945 | FLOWMETER NIPPLE ADAPTOR | Cardio-Search , Ltd. | Nov 17, 1993 | SESE |
| K920783 | OXYGEN FLOW CONTROLLER | Puritan Bennett Corp. | Sep 18, 1992 | SESE |
| K872038 | NEB-U-VENT | Design Technologies, Inc. | Aug 10, 1987 | SESE |
| K871262 | MODIFIED NOFLO I | Design Technologies, Inc. | Jul 21, 1987 | SESE |
| K863613 | NO-FLO I | Design Technologies, Inc. | Dec 15, 1986 | SESE |
| K863659 | FLOW INTERRUPTION INDICATOR | Salter Labs | Oct 15, 1986 | SESE |
| K863657 | OXYGEN CONSERVATOR | Salter Labs | Oct 15, 1986 | SESE |
| K823775 | BORDON GAGE REGULATOR #BG | Timeter Instrument Corp. | Jan 14, 1983 | SESE |
| K802037 | VITAMIN B12 FOLATE RADIOASSAY | Corning Medical & Scientific | Nov 21, 1980 | SESE |
Top Applicants
- Design Technologies, Inc. — 3 clearances
- Salter Labs — 2 clearances
- Timeter Instrument Corp. — 1 clearance
- Puritan Bennett Corp. — 1 clearance
- Corning Medical & Scientific — 1 clearance
