Calibrator, Dynamic
FDA 510(k) K781692 · Waters Assoc., Inc.
510(k) numberK781692
Submission
- Device name
- Calibrator, Dynamic
- Applicant
- Waters Assoc., Inc.
Mchenry, IL, US - Received
- October 4, 1978
- Decision date
- November 29, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXM – Densitometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K791892 | Tape-A-TraceDXM · Traditional | Instromedix, Inc. | 11/05/1979SE |
More from Instromedix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K811975 | Model 480 Variable Wavelength Ultra ViolJJQ · Traditional | 07/27/1981SE |
| K802481 | 7FRENCH Flow Directed Triple Lumen CathDYG · Traditional | 10/31/1980SE |
| K801852 | MRM-2 Oxygen Consumption MonitorBZL · Traditional | 08/20/1980SE |
| K801431 | Pan-Am Myelogram TrayFMI · Traditional | 08/12/1980SE |
| K791661 | System Controller 720 SeriesKIE · Traditional | 09/24/1979SE |
| K791026 | 4F Sterile Balloon-Less, Catheter 913-28KRB · Traditional | 06/22/1979SE |
| K790145 | Solvent Delivery SystemKIE · Traditional | 02/15/1979SE |
| K782175 | Cartridge Holder, RCM 100KIE · Traditional | 02/15/1979SE |
| K781805 | Cardiac Computers, CO-10 & CO-10RDXG · Traditional | 01/29/1979SE |
| K781915 | Data ModuleKIE · Traditional | 01/10/1979SE |
Questions and answers
When was Calibrator, Dynamic cleared by the FDA?
Calibrator, Dynamic (K781692) received a 510(k) decision of Substantially Equivalent on November 29, 1978, 56 days after the submission was received.
What is the product code of K781692?
The FDA product code is DXM – Densitometer, a Class II (moderate risk) device regulated under 21 CFR 870.1450.