Linde Oxygen Therapy Flowmeters, L33-L34
FDA 510(k) K791069 · Union Carbide Corp.
510(k) numberK791069
Submission
- Device name
- Linde Oxygen Therapy Flowmeters, L33-L34
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- June 12, 1979
- Decision date
- June 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAX – Flowmeter, Tube, Thorpe, Back-Pressure Compensated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2340
- Specialty
- Anesthesiology
Other 510(k)s with product code CAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923781 | MXR-2000 FlowmeterCAX · Traditional | Porter Instrument Co., Inc. | 06/10/1993SE |
| K910316 | Ohmeda - Low Flow FlowmeterCAX · Traditional | Ohmeda Medical | 04/12/1991SE |
| K884973 | FR6000 FlowmeterCAX · Traditional | Key Instruments | 01/17/1989SE |
| K872718 | Series D FlowmeterCAX · Traditional | Puritan Bennett Corp. | 08/05/1987SE |
| K871452 | Classic (TM) 200 Oxygen FlowmeterCAX · Traditional | The Timeter Group | 06/22/1987SE |
| K862797 | Airco 2000 Series FlowmetersCAX · Traditional | Airco, Inc. | 08/08/1986SE |
| K854067 | Select FlowmeterCAX · Traditional | Precision Medical, Inc. | 10/29/1985SE |
| K851288 | Oxygen Delivery Measuring DeviceCAX · Traditional | Bar-Dix, Inc. | 09/03/1985SE |
| K850559 | Pressure Relief AdaptorCAX · Traditional | Precision Medical, Inc. | 04/25/1985SE |
| K850560 | Flowmeter, Backpressure Compensated, Thorpe TubeCAX · Traditional | Precision Medical, Inc. | 04/17/1985SE |
More from Precision Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830337 | Mark III Oxygen Walker Sys-Low PressBYJ · Traditional | 03/17/1983SE |
| K820836 | Mark III Oxygen Walker SystemBYJ · Traditional | 04/15/1982SE |
| K820535 | Laser Gas MixturesEWG · Traditional | 03/31/1982SE |
| K812536 | Linde Mark IIBYJ · Traditional | 09/23/1981SE |
| K810732 | Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional | 03/27/1981SE |
| K810596 | Centrifi Chem System 400 AnalyzerJJE · Traditional | 03/17/1981SE |
| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802741 | Centrifichem Comb. Serum-Based Calib.JIX · Traditional | 12/10/1980SE |
| K802520 | Centrifichem Pipettor Accuracy Calib.JQW · Traditional | 11/12/1980SE |
Questions and answers
When was Linde Oxygen Therapy Flowmeters, L33-L34 cleared by the FDA?
Linde Oxygen Therapy Flowmeters, L33-L34 (K791069) received a 510(k) decision of Substantially Equivalent on June 27, 1979, 15 days after the submission was received.
What is the product code of K791069?
The FDA product code is CAX – Flowmeter, Tube, Thorpe, Back-Pressure Compensated, a Class I (low risk) device regulated under 21 CFR 868.2340.