The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Dura-y Oxygen Transducer, Ear Clip.
| Device ID | K944760 |
| 510k Number | K944760 |
| Device Name: | DURA-Y OXYGEN TRANSDUCER, EAR CLIP |
| Classification | Oximeter, Ear |
| Applicant | NELLCOR, INC. 2391 FENTON ST. Chula Vista, CA 91914 -3511 |
| Contact | Gerald Palecki |
| Correspondent | Gerald Palecki NELLCOR, INC. 2391 FENTON ST. Chula Vista, CA 91914 -3511 |
| Product Code | DPZ |
| CFR Regulation Number | 870.2710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1994-10-17 |