510(k) K955887
- Device
- NEWMED ABP-LITE
- Applicant
- NEWMED CORP.
- 510(k) number
- K955887
- Product code
- DXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-05
- Date received
- 1995-12-28
- Regulation
- 870.1270
- Classification name
- System, Phonocatheter, Intracavitary
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD R STONE
- Address
- 1575 Eye St. NW Washington DC US 20005 20005
Source Documents#
Other 510(k) Records For Product Code DXW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972020 | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR | Cas Medical Systems, Inc. | 1998-05-05 |
| K802830 | MILLAR MIKRO-TIP CATHETER PHONOTRANS | Millar Instruments, Inc. | 1980-12-10 |
| K800222 | MODEL 412 ELECTROFLUIDIC MANOMETER | Med-Tek Corp. | 1980-02-29 |
| K800179 | INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR | Sphygmetrics, Inc. | 1980-02-11 |
Legacy Summary#
summary
FDA Review#
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