SuperNO2VA Device
FDA 510(k) clearance K163277 · decided 2017-10-13
Clearance details
- K-number
- K163277
- Device name
- SuperNO2VA Device
- Applicant
- Revolutionary Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-21
- Decision date
- 2017-10-13
- Days to decision
- 326 days
- Clearance type
- Traditional
- Product code
- BSJ
- Device class
- 1
- Regulation number
- 868.5550
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tucson, AZ, 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 |
|---|---|---|
| ANESTHESIA/RESPIRATORY FACE MASK (K953107) | Medical Marketing Concepts | 1995-08-15 |
| ANESTHESIA FACE MASK (K953295) | Mallinckrodt Medical | 1995-08-11 |
| BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (K952689) | Owens-Brigam Medical Co. | 1995-07-11 |
| AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (K951043) | Promedic, Inc. | 1995-06-07 |
| DISPOSABLE ADHESIVE FACE MASK (K950771) | Advanced Warming Systems, Inc. | 1995-03-10 |
| MASK, GAS, ANESTHETIC (K945894) | Hans Rudolph, Inc. | 1995-01-27 |
| DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (K945440) | Fvtnks | 1994-11-08 |
| DISPOSABLE, PREFORMED FACE MASK (K944157) | Meridian Medical Systems, Inc. | 1994-10-03 |
| NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (K932147) | Hans Rudolph, Inc. | 1993-08-20 |
| AMBU DISPOSABLE FACE MASK (K932014) | Ambu, Inc. | 1993-06-22 |
| IAS ANESTHESIA MASK (K915558) | Ias | 1992-04-08 |
| VENTLAB VENT-MASK, CAT# VR 0010/20/30 (K903881) | Ventlab Corp. | 1990-09-04 |
Recalls involving this device
No recalls on record reference this clearance.