The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Gental Pulse.
| Device ID | K950238 |
| 510k Number | K950238 |
| Device Name: | GENTAL PULSE |
| Classification | Tester, Pulp |
| Applicant | PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Contact | Nelson J Geneusa |
| Correspondent | Nelson J Geneusa PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Product Code | EAT |
| CFR Regulation Number | 872.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-20 |
| Decision Date | 1995-05-09 |