The following data is part of a premarket notification filed by Kells Medical, Inc. with the FDA for Sn-100 Doctor's Round.
| Device ID | K823226 |
| 510k Number | K823226 |
| Device Name: | SN-100 DOCTOR'S ROUND |
| Classification | Unit, Examining/treatment, Ent |
| Applicant | KELLS MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETF |
| CFR Regulation Number | 874.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-29 |
| Decision Date | 1982-11-22 |