NEBULIZER, MEDICINAL
FDA 510(k) clearance K802430 · decided 1980-10-23
Clearance details
- K-number
- K802430
- Device name
- NEBULIZER, MEDICINAL
- Applicant
- Dhd Medical Products Div. Diemolding Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-06
- Decision date
- 1980-10-23
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- EPN
- Device class
- 1
- Regulation number
- 874.5220
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DEVILBISS MODEL 6300D (K896090) | Devilbiss Health Care, Inc. | 1989-11-30 |
Recalls involving this device
No recalls on record reference this clearance.