510(k) K800179
- Device
- INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR
- Applicant
- SPHYGMETRICS, INC.
- 510(k) number
- K800179
- Product code
- DXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-02-11
- Date received
- 1980-01-29
- Regulation
- 870.1270
- Classification name
- System, Phonocatheter, Intracavitary
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K955887 | NEWMED ABP-LITE | Newmed Corp. | 1996-09-05 |
| K802830 | MILLAR MIKRO-TIP CATHETER PHONOTRANS | Millar Instruments, Inc. | 1980-12-10 |
| K800222 | MODEL 412 ELECTROFLUIDIC MANOMETER | Med-Tek Corp. | 1980-02-29 |
Legacy Summary#
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FDA Review#
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