The following data is part of a premarket notification filed by Physio-dyne Instrument Corp. with the FDA for Physio-dyne Easi (easy Analog Sampling Interface).
| Device ID | K892670 |
| 510k Number | K892670 |
| Device Name: | PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE) |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | PHYSIO-DYNE INSTRUMENT CORP. 35 JEANETTE DRIVE, P.O. BOX 209 Massapequa, NY 11758 |
| Contact | Donald B Falk |
| Correspondent | Donald B Falk PHYSIO-DYNE INSTRUMENT CORP. 35 JEANETTE DRIVE, P.O. BOX 209 Massapequa, NY 11758 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-09-22 |