VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW
FDA 510(k) clearance K851480 · decided 1985-05-07
Clearance details
- K-number
- K851480
- Device name
- VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW
- Applicant
- Vygon Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-15
- Decision date
- 1985-05-07
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- LAE
- Device class
- 2
- Regulation number
- 862.3270
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| MOUTH-TO-MOUTH SHIELD APPLICATOR (K832590) | Mem, Inc. | 1983-10-14 |
Recalls involving this device
No recalls on record reference this clearance.