The following data is part of a premarket notification filed by Equilibrated Bio Systems, Inc. with the FDA for Ebs2605 Infant Hugger.
| Device ID | K892705 |
| 510k Number | K892705 |
| Device Name: | EBS2605 INFANT HUGGER |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | EQUILIBRATED BIO SYSTEMS, INC. 900 WALT WHITMAN RD. Melville, NY 11747 |
| Contact | Alex Stenzler |
| Correspondent | Alex Stenzler EQUILIBRATED BIO SYSTEMS, INC. 900 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-14 |
| Decision Date | 1989-10-27 |