AIRES
FDA 510(k) clearance K920043 · decided 1993-06-16
Clearance details
- K-number
- K920043
- Device name
- AIRES
- Applicant
- Viva-Tek Assoc., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-06
- Decision date
- 1993-06-16
- Days to decision
- 527 days
- Clearance type
- Traditional
- Product code
- CBN
- Device class
- 2
- Regulation number
- 868.5430
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Medford, 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 |
|---|---|---|
| Nitronox Scavenger Plus (K223452) | Parker Hannifin Corporation | 2023-03-05 |
| Dynamic Gas Scavenging System 2 (DGSS - 2) (K193646) | Anesthetic Gas Reclamation, Inc. | 2020-12-04 |
| MINISCAV (K160950) | Sedation Systems, LLC | 2017-05-05 |
| ISO-GARD MASK (K142138) | Teleflexmedical, Inc. | 2014-10-30 |
| ISO-GARD MASK (K132729) | Teleflexmedical, Inc. | 2014-01-09 |
| ISO-GARD CLEARAIR MASK (K123176) | Teleflexmedical, Inc. | 2013-02-14 |
| ACTIVE WASTE GAS SCAVENGER (K110930) | G. Dundas Co.,Inc. | 2011-06-23 |
| VAPOR-CLEAR, MODEL 100 (K092031) | Axon Medical, Inc. | 2010-04-16 |
| PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (K080039) | G. Dundas Co.,Inc. | 2008-04-14 |
| MINRAD INC. NASAL SCAVENGING CIRCUIT (K072255) | Minrad, Inc. | 2007-10-18 |
| DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (K063519) | Anesthetic Gas Reclamation, LLC | 2006-12-01 |
| ANEFIN, MODEL 100 (K033028) | Axon Medical | 2005-07-22 |
Recalls involving this device
No recalls on record reference this clearance.