The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Oximax Softcare Sensors, Models Sc-a, Sc-pr, Sc-neo, Sc-n.
| Device ID | K030930 |
| 510k Number | K030930 |
| Device Name: | OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N |
| Classification | Oximeter |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Gina To |
| Correspondent | Gina To NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-25 |
| Decision Date | 2003-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884522042611 | K030930 | 000 |
| 10884522042451 | K030930 | 000 |
| 10884522042437 | K030930 | 000 |
| 20884522042557 | K030930 | 000 |
| 20884522042830 | K030930 | 000 |