TAPE-A-TRACE
FDA 510(k) clearance K791892 · decided 1979-11-05
Clearance details
- K-number
- K791892
- Device name
- TAPE-A-TRACE
- Applicant
- Instromedix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-09-25
- Decision date
- 1979-11-05
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- DXM
- Device class
- 2
- Regulation number
- 870.1450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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 |
|---|---|---|
| CALIBRATOR, DYNAMIC (K781692) | Waters Assoc., Inc. | 1978-11-29 |
Recalls involving this device
No recalls on record reference this clearance.