The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Circuit Breathing (w Connector, Adapter Y Piece).
| Device ID | K890822 |
| 510k Number | K890822 |
| Device Name: | CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE) |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | VENTLAB CORP. 221 GRACIE PLACE Hackensack, NJ 07601 |
| Contact | Richard Plaatsman |
| Correspondent | Richard Plaatsman VENTLAB CORP. 221 GRACIE PLACE Hackensack, NJ 07601 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-17 |
| Decision Date | 1989-05-05 |