V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES
FDA 510(k) clearance K851082 · decided 1985-07-22
Clearance details
- K-number
- K851082
- Device name
- V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES
- Applicant
- American V. Mueller
- Decision
- Substantially Equivalent
- Date received
- 1985-03-18
- Decision date
- 1985-07-22
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- ENW
- Device class
- 1
- Regulation number
- 874.4175
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch American V. Mueller
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SILICONE SOFT-PAK EPISTAXIS CATHETER (K832476) | Axiom Medical, Inc. | 1983-11-03 |
Recalls involving this device
No recalls on record reference this clearance.