The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Nellcor Indgo Manual Resuscitator.
| Device ID | K023494 |
| 510k Number | K023494 |
| Device Name: | NELLCOR INDGO MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-18 |
| Decision Date | 2003-02-07 |
| Summary: | summary |