The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Heel Snuggler, Model 99047.
| Device ID | K040044 |
| 510k Number | K040044 |
| Device Name: | HEEL SNUGGLER, MODEL 99047 |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | N.e. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-01-12 |
| Decision Date | 2004-01-27 |
| Summary: | summary |