The following data is part of a premarket notification filed by Physio-dyne Industrument Corp. with the FDA for Physio-dyne Ecg/hr 3.
| Device ID | K854847 |
| 510k Number | K854847 |
| Device Name: | PHYSIO-DYNE ECG/HR 3 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | PHYSIO-DYNE INDUSTRUMENT CORP. 35 JEANETTE DR. P.O. BOX 209 Massapequa, NY 11758 |
| Contact | Donald B Falk |
| Correspondent | Donald B Falk PHYSIO-DYNE INDUSTRUMENT CORP. 35 JEANETTE DR. P.O. BOX 209 Massapequa, NY 11758 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-04 |
| Decision Date | 1986-06-16 |