510(k) K791892
- Device
- TAPE-A-TRACE
- Applicant
- INSTROMEDIX, INC.
- 510(k) number
- K791892
- Product code
- DXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-11-05
- Date received
- 1979-09-25
- Regulation
- 870.1450
- Classification name
- Densitometer
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DXM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K781692 | CALIBRATOR, DYNAMIC | Waters Assoc., Inc. | 1978-11-29 |
Legacy Summary#
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FDA Review#
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