The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Warmtouch Cardiac Blanket,catalog # 503-0860.
| Device ID | K014121 |
| 510k Number | K014121 |
| Device Name: | WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 |
| Classification | System, Thermal Regulating |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Anthony Mullin |
| Correspondent | Anthony Mullin NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-17 |
| Decision Date | 2002-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521061378 | K014121 | 000 |