VOLUMATIC
FDA 510(k) clearance K844169 · decided 1984-11-09
Clearance details
- K-number
- K844169
- Device name
- VOLUMATIC
- Applicant
- Glaxo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-25
- Decision date
- 1984-11-09
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- KCD
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Research Triangle, NC, 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 |
|---|---|---|
| ESOPHAGEAL BOUGIES (K822258) | Kelleher Corp. | 1982-08-25 |
| JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE (K800623) | Pilling Co. | 1980-04-24 |
Recalls involving this device
No recalls on record reference this clearance.