The following data is part of a premarket notification filed by Children's Health First, Inc. with the FDA for Statstrap Neonatal Incubator Safety Strap, Models Ss-001, Ss-002.
| Device ID | K081264 |
| 510k Number | K081264 |
| Device Name: | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 |
| Classification | Restraint, Protective |
| Applicant | CHILDREN'S HEALTH FIRST, INC. 5249 SHELLEY PLACE Carlsbad, CA 92008 |
| Contact | Roger T Vaughan |
| Correspondent | Roger T Vaughan CHILDREN'S HEALTH FIRST, INC. 5249 SHELLEY PLACE Carlsbad, CA 92008 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-05 |
| Decision Date | 2009-02-13 |
| Summary: | summary |