The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Infant/pediatric Resuscitation Circuit W/apl.
| Device ID | K911465 |
| 510k Number | K911465 |
| Device Name: | INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Alberto Velez |
| Correspondent | Alberto Velez VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-10-18 |