AUDIOPRAT ENDOSCOPE
FDA 510(k) clearance K903012 · decided 1990-10-09
Clearance details
- K-number
- K903012
- Device name
- AUDIOPRAT ENDOSCOPE
- Applicant
- S.C.D.P.I. of Florida, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-11
- Decision date
- 1990-10-09
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- EHB
- Device class
- 1
- Regulation number
- 872.1840
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ormond Beach, FL, 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 |
|---|---|---|
| WINGMASTER (K921355) | Innovators, Inc. | 1992-09-25 |
| X-RAY COLLIMATOR X-CJD (K834606) | Knochen Dental Laboratory | 1984-02-21 |
| X-RAY SHIELD (K833558) | Moyco Industries, Inc. | 1984-01-13 |
| X-RAY COLLIMATOR (K781675) | General X-Ray, Inc. | 1978-12-04 |
Recalls involving this device
No recalls on record reference this clearance.