510(k) K910316
- Device
- OHMEDA - LOW FLOW FLOWMETER
- Applicant
- OHMEDA MEDICAL
- 510(k) number
- K910316
- Product code
- CAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-12
- Date received
- 1991-01-24
- Regulation
- 868.2340
- Classification name
- Flowmeter, Tube, Thorpe, Back-pressure Compensated
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALBERTO F PROFUMO
- Address
- 9065 Guilford Rd. Columbia MD US 21046 21046
FDA Registration Numbers#
- 1526809
- 2225311
- 1044295
- 1121335
- 3022528821
- 3003674698
- 1836161
- 2518157
- 1530881
- 3043607924
- 3005347827
- 3010008150
- 9681409
- 9614084
- 3021244152
- 3009162879
- 2085602
- 3020751316
- 3008281139
- 3020614
- 3005380088
- 3003207908
- 3006446479
- 3007360714
- 3010834934
- 3009197857
- 9681758
- 3006210673
- 2523148
- 1419185
- 3006991053
- 9611451
- 3006157842
- 1119231
- 3033859527
- 1722070
- 3015134079
- 3001650535
- 1924066
- 3011780089
- 1039215
- 3013156250
- 1314417
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CAX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923781 | MXR-2000 FLOWMETER | Porter Instrument Co., Inc. | 1993-06-10 |
| K884973 | FR6000 FLOWMETER | Key Instruments | 1989-01-17 |
| K872718 | SERIES D FLOWMETER | Puritan Bennett Corp. | 1987-08-05 |
| K871452 | CLASSIC (TM) 200 OXYGEN FLOWMETER | The Timeter Group | 1987-06-22 |
| K862797 | AIRCO 2000 SERIES FLOWMETERS | Airco, Inc. | 1986-08-08 |
| K854067 | SELECT FLOWMETER | Precision Medical, Inc. | 1985-10-29 |
| K851288 | OXYGEN DELIVERY MEASURING DEVICE | Bar-Dix, Inc. | 1985-09-03 |
| K850559 | PRESSURE RELIEF ADAPTOR | Precision Medical, Inc. | 1985-04-25 |
| K850560 | FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE | Precision Medical, Inc. | 1985-04-17 |
| K834260 | RECON-2 FLOW CONTROLLER | Precision Metering, Inc. | 1984-01-10 |
| K812419 | PRESET FLOWMETER | Timeter Instrument Corp. | 1981-09-21 |
| K812183 | TIMETER-PRODUCED PURITAN BENNETT AIR ADP | Timeter Instrument Corp. | 1981-08-18 |
| K812128 | RECON 1 | Precision Metering, Inc. | 1981-08-18 |
| K802659 | RESPIRATORY THERAPY FLOWMETER | Design & Manufacturing Consultants | 1980-11-12 |
| K802311 | MO8 OXYGEN FLOWMETER | Timeter Instrument Corp. | 1980-10-23 |
Legacy Summary#
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FDA Review#
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