The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Adult Circle Breath Circuit W/intern Gas Samp Line.
| Device ID | K905450 |
| 510k Number | K905450 |
| Device Name: | ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| 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 | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-05 |
| Decision Date | 1991-07-01 |