510(k) K781692
- Device
- CALIBRATOR, DYNAMIC
- Applicant
- WATERS ASSOC., INC.
- 510(k) number
- K781692
- Product code
- DXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-11-29
- Date received
- 1978-10-04
- 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 |
|---|---|---|---|
| K791892 | TAPE-A-TRACE | Instromedix, Inc. | 1979-11-05 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases