Model 412 Electrofluidic Manometer
FDA 510(k) K800222 · Med-Tek Corp.
510(k) numberK800222
Submission
- Device name
- Model 412 Electrofluidic Manometer
- Applicant
- Med-Tek Corp.
Mchenry, IL, US - Received
- February 4, 1980
- Decision date
- February 29, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXW – System, Phonocatheter, Intracavitary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1270
- Specialty
- Cardiovascular
Other 510(k)s with product code DXW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972020 | Oscillomate Non-Invasive Blood Pressure MonitorDXW · Traditional | Cas Medical Systems, Inc. | 05/05/1998SE |
| K955887 | Newmed Abp-LiteDXW · Traditional | Newmed Corp. | 09/05/1996SE |
| K802830 | Millar Mikro-Tip Catheter PhonotransDXW · Traditional | Millar Instruments, Inc. | 12/10/1980SE |
| K800179 | Infrasonde Auto/Inflator Elec. VibratorDXW · Traditional | Sphygmetrics, Inc. | 02/11/1980SE |
More from Sphygmetrics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903234 | F-19 Total Hip ProsthesisJDI · Traditional | 10/10/1990SE |
| K901687 | F-24 Femoral Hip ProsthesisLWJ · Traditional | 09/07/1990SE |
| K901451 | F-20 Cemented Metal-Backed Acetabular CupJDI · Traditional | 08/31/1990SN |
| K900428 | Anesthesia Breathing CircuitsCAI · Traditional | 08/17/1990SE |
| K901626 | H.N. Metal Backed Acetabular Cup, NoncementedKWA · Traditional | 08/14/1990SE |
| K901594 | H.N. Total Hip ProsthesisLWJ · Traditional | 08/03/1990SE |
| K901480 | F-20 Total Hip ProsthesisJDI · Traditional | 06/12/1990SE |
| K901273 | L.M.S. Self-Detachable Broach with StopHTY · Traditional | 06/05/1990SE |
| K901272 | Orion Blade Plate for Tibial OsteotomyKTT · Traditional | 04/23/1990SE |
| K901240 | Astel Non-Metal Backed Acetabular Cup for CementedJDI · Traditional | 03/26/1990SE |
Questions and answers
When was Model 412 Electrofluidic Manometer cleared by the FDA?
Model 412 Electrofluidic Manometer (K800222) received a 510(k) decision of Substantially Equivalent on February 29, 1980, 25 days after the submission was received.
What is the product code of K800222?
The FDA product code is DXW – System, Phonocatheter, Intracavitary, a Class II (moderate risk) device regulated under 21 CFR 870.1270.