FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALIBRATOR, DYNAMIC
K Number: K781692
·
Decision Nov 29, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
16
Review Days
56
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Basic Information
- Device Name
- CALIBRATOR, DYNAMIC
- K Number
- K781692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Waters Assoc., Inc.
- Date Received
- October 4, 1978
- Decision Date
- November 29, 1978
- Product Code
- DXM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXM | Densitometer | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXM), ordered by most recent decision date.
View allOther Clearances by Waters Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K811975 | MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL | Jul 27, 1981 | Substantially Equivalent |
| K802481 | 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH | Oct 31, 1980 | Substantially Equivalent |
| K801852 | MRM-2 OXYGEN CONSUMPTION MONITOR | Aug 20, 1980 | Substantially Equivalent |
| K801431 | PAN-AM MYELOGRAM TRAY | Aug 12, 1980 | Substantially Equivalent |
| K791661 | SYSTEM CONTROLLER 720 SERIES | Sep 24, 1979 | Substantially Equivalent |
| K791026 | 4F STERILE BALLOON-LESS, CATHETER 913-28 | Jun 22, 1979 | Substantially Equivalent |
| K782175 | CARTRIDGE HOLDER, RCM 100 | Feb 15, 1979 | Substantially Equivalent |
| K790145 | SOLVENT DELIVERY SYSTEM | Feb 15, 1979 | Substantially Equivalent |
| K781805 | CARDIAC COMPUTERS, CO-10 & CO-10R | Jan 29, 1979 | Substantially Equivalent |
| K781915 | DATA MODULE | Jan 10, 1979 | Substantially Equivalent |