Newmed Abp-Lite
FDA 510(k) K955887 · Newmed Corp.
510(k) numberK955887
Submission
- Device name
- Newmed Abp-Lite
- Applicant
- Newmed Corp.
Washington, DC, US - Received
- December 28, 1995
- Decision date
- September 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K802830 | Millar Mikro-Tip Catheter PhonotransDXW · Traditional | Millar Instruments, Inc. | 12/10/1980SE |
| K800222 | Model 412 Electrofluidic ManometerDXW · Traditional | Med-Tek Corp. | 02/29/1980SE |
| K800179 | Infrasonde Auto/Inflator Elec. VibratorDXW · Traditional | Sphygmetrics, Inc. | 02/11/1980SE |
More from Sphygmetrics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935955 | DoserCAF · Traditional | 09/16/1994SE |
Questions and answers
When was Newmed Abp-Lite cleared by the FDA?
Newmed Abp-Lite (K955887) received a 510(k) decision of Substantially Equivalent on September 5, 1996, 252 days after the submission was received.
What is the product code of K955887?
The FDA product code is DXW – System, Phonocatheter, Intracavitary, a Class II (moderate risk) device regulated under 21 CFR 870.1270.