DOWNS ADJUSTABLE FLOW GENERATOR
FDA 510(k) clearance K831503 · decided 1983-09-12
Clearance details
- K-number
- K831503
- Device name
- DOWNS ADJUSTABLE FLOW GENERATOR
- Applicant
- Vital Signs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-11
- Decision date
- 1983-09-12
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- BYE
- Device class
- 2
- Regulation number
- 868.5965
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- East Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Besmed PEEP Valve (K160112) | Besmed Health Business Corp | 2016-04-29 |
| DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (K133957) | Galemed Corp. | 2014-04-14 |
| B&B BUBBLER (K133210) | S & T Medical Technologies, Inc. | 2014-03-28 |
| PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES (K122610) | Sen MU Technology Co., Ltd. | 2013-08-05 |
| O_TWO CPAP SYSTEM (K112546) | O-Two Medical Technologies, Inc. | 2011-12-27 |
| WATERPAP VALVE (K110713) | Airways Development, LLC | 2011-09-12 |
| NEOPIP PATIENT CIRCUIT WITH PEEP (K103833) | Neoforce Group, Inc. | 2011-04-20 |
| VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (K092029) | Draeger Medical AG & Co. KG | 2010-08-06 |
| MERCURY CPAP (K090710) | Mercury Medical | 2009-08-20 |
| BABI*PLUS BUBBLE PAP VALVE (K090317) | A Plus Medical | 2009-05-20 |
| MERCURY MEDICAL PEEP VALVE (K081266) | Mercury Enterprizes Dba Mercury Medical | 2009-03-05 |
| PULMODYNE CHF FLOW GENERATOR SYSTEM (K080256) | Pulmodyne | 2008-05-09 |
Recalls involving this device
No recalls on record reference this clearance.