The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Neonatal Ventilator Circuit.
| Device ID | K903083 |
| 510k Number | K903083 |
| Device Name: | NEONATAL VENTILATOR CIRCUIT |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Contact | Jorge Haider |
| Correspondent | Jorge Haider HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-12 |
| Decision Date | 1990-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704659870 | K903083 | 000 |
| 24026704660166 | K903083 | 000 |
| 24026704598155 | K903083 | 000 |
| 24026704598063 | K903083 | 000 |
| 24026704597998 | K903083 | 000 |
| 24026704597967 | K903083 | 000 |
| 24026704597936 | K903083 | 000 |