Company ยท US
Devilbiss Health Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1997. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 6 |
| BZD | Ventilator, Non-Continuous (Respirator) | 5 |
| CAW | Generator, Oxygen, Portable | 4 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 3 |
| BTI | Compressor, Air, Portable | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 2 |
| NFB | Conserver, Oxygen | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| BYG | Mask, Oxygen | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| EPN | Pump, Nebulizer, Manual | 1 |
| MNR | Ventilatory Effort Recorder | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 1997 | K963349 | DEVILBISS 8650D Devilbiss Health Care, Inc. | BTI |
| Apr 15, 1997 | K970289 | COMPRESSOR/NEBULIZER #3650 Devilbiss Health Care, Inc. | CAF |
| Oct 21, 1996 | K961126 | PULSE DOSE SERIES Devilbiss Health Care, Inc. | NFB |
| Feb 8, 1996 | K950849 | MODEL #7354 Devilbiss Health Care, Inc. | BZD |
| Jan 31, 1996 | K952491 | MODEL 7355 Devilbiss Health Care, Inc. | BZD |
| Jan 30, 1996 | K952249 | JET NEBULIZER Devilbiss Health Care, Inc. | CAF |
| Nov 9, 1995 | K953815 | 5 LPM OXYGEN CONCENTRATOR Devilbiss Health Care, Inc. | CAW |
| Sep 6, 1995 | K952037 | 3 LPM OXYGEN CONCENTRATOR Devilbiss Health Care, Inc. | CAW |
| Aug 24, 1995 | K946095 | DEVILBISS MODEL 5500 Devilbiss Health Care, Inc. | CAF |
| Apr 21, 1995 | K944611 | MODEL# 7500 SURVEYOR Devilbiss Health Care, Inc. | MNR |
| Nov 10, 1994 | K935979 | CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM Devilbiss Health Care, Inc. | BZD |
| Sep 30, 1993 | K931015 | DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER Devilbiss Health Care, Inc. | BTI |
| Jun 7, 1993 | K924152 | KEYSTONE CONCENTRATOR, MODEL PV5L Devilbiss Health Care, Inc. | CAW |
| Feb 23, 1993 | K923888 | DEVILBISS MODEL 5650 PULMO-AIDE Devilbiss Health Care, Inc. | CAF |
| Sep 17, 1992 | K921499 | SEAL RING FOR NASAL CPAP Devilbiss Health Care, Inc. | BYG |
| Jul 17, 1992 | K913392 | OXYGEN SENSING DEVICE, MODIFICATION Devilbiss Health Care, Inc. | CCL |
| Dec 11, 1991 | K913316 | DEVILBISS MODEL 7427D Devilbiss Health Care, Inc. | CAF |
| Jul 31, 1991 | K911896 | DEVILBISS MODEL 5000 Devilbiss Health Care, Inc. | CAF |
| May 1, 1991 | K904344 | SLEEPER MASK SYSTEM Devilbiss Health Care, Inc. | BZD |
| Mar 26, 1991 | K904766 | DEVILBISS MODEL 7352 SERIES Devilbiss Health Care, Inc. | BZD |
| Apr 23, 1990 | K900602 | DEVILBISS AP-50 COMPRESSOR/NEBULIZER Devilbiss Health Care, Inc. | BTT |
| Feb 1, 1990 | K896457 | DEVILBISS MODEL PV02 SERIES Devilbiss Health Care, Inc. | CAW |
| Nov 30, 1989 | K896090 | DEVILBISS MODEL 6300D Devilbiss Health Care, Inc. | EPN |
| Oct 13, 1989 | K894441 | DEVILBISS MODEL 6610D Devilbiss Health Care, Inc. | CCQ |
| Oct 6, 1989 | K894244 | DEVILBISS MODEL 8500D AND 8500D-608 Devilbiss Health Care, Inc. | CCQ |
| Sep 18, 1989 | K894424 | DEVILBISS MODEL 7351 SERIES Devilbiss Health Care, Inc. | BYE |
| Sep 8, 1989 | K894690 | CPAP MASK Devilbiss Health Care, Inc. | BYE |
| Jun 23, 1989 | K893388 | DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM Devilbiss Health Care, Inc. | BYE |
| Apr 6, 1989 | K890141 | DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE) Devilbiss Health Care, Inc. | NFB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||