ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202
FDA 510(k) clearance K800364 · decided 1980-03-12
Clearance details
- K-number
- K800364
- Device name
- ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202
- Applicant
- Hoffrel Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-20
- Decision date
- 1980-03-12
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- DKX
- Device class
- 2
- Regulation number
- 862.3150
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (K030211) | Icn Biomedicals, Inc. | 2003-06-13 |
Recalls involving this device
No recalls on record reference this clearance.