Devilbiss Health Care, Inc.
Somerset, PA, US
Devilbiss Health Care, Inc. appears in FDA device records in Somerset, PA. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Devilbiss Health Care, Inc. between 1989 and 1997. The busiest year on record is 1989, with 7. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 7 |
| 1990 | 2 |
| 1991 | 4 |
| 1992 | 2 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 4 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K963349 | DEVILBISS 8650D | BTI | Substantially Equivalent | |
| K970289 | COMPRESSOR/NEBULIZER #3650 | CAF | Substantially Equivalent | |
| K961126 | PULSE DOSE SERIES | NFB | Substantially Equivalent | |
| K950849 | MODEL #7354 | BZD | Substantially Equivalent | |
| K952491 | MODEL 7355 | BZD | Substantially Equivalent | |
| K952249 | JET NEBULIZER | CAF | Substantially Equivalent | |
| K953815 | 5 LPM OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | |
| K952037 | 3 LPM OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | |
| K946095 | DEVILBISS MODEL 5500 | CAF | Substantially Equivalent | |
| K944611 | MODEL# 7500 SURVEYOR | MNR | Substantially Equivalent | |
| K935979 | CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM | BZD | Substantially Equivalent | |
| K931015 | DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER | BTI | Substantially Equivalent | |
| K924152 | KEYSTONE CONCENTRATOR, MODEL PV5L | CAW | Substantially Equivalent | |
| K923888 | DEVILBISS MODEL 5650 PULMO-AIDE | CAF | Substantially Equivalent | |
| K921499 | SEAL RING FOR NASAL CPAP | BYG | Substantially Equivalent | |
| K913392 | OXYGEN SENSING DEVICE, MODIFICATION | CCL | Substantially Equivalent | |
| K913316 | DEVILBISS MODEL 7427D | CAF | Substantially Equivalent for Some Indications | |
| K911896 | DEVILBISS MODEL 5000 | CAF | Substantially Equivalent | |
| K904344 | SLEEPER MASK SYSTEM | BZD | Substantially Equivalent | |
| K904766 | DEVILBISS MODEL 7352 SERIES | BZD | Substantially Equivalent | |
| K900602 | DEVILBISS AP-50 COMPRESSOR/NEBULIZER | BTT | Substantially Equivalent | |
| K896457 | DEVILBISS MODEL PV02 SERIES | CAW | Substantially Equivalent | |
| K896090 | DEVILBISS MODEL 6300D | EPN | Substantially Equivalent | |
| K894441 | DEVILBISS MODEL 6610D | CCQ | Substantially Equivalent | |
| K894244 | DEVILBISS MODEL 8500D AND 8500D-608 | CCQ | Substantially Equivalent | |
| K894424 | DEVILBISS MODEL 7351 SERIES | BYE | Substantially Equivalent | |
| K894690 | CPAP MASK | BYE | Substantially Equivalent | |
| K893388 | DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM | BYE | Substantially Equivalent | |
| K890141 | DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE) | NFB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTICompressor, Air, Portable
- NFBConserver, Oxygen
- CAWGenerator, Oxygen, Portable
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- BYGMask, Oxygen
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- EPNPump, Nebulizer, Manual
- BZDVentilator, Non-Continuous (Respirator)
- MNRVentilatory Effort Recorder
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain