The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Adult Ventilator Tester Vt-1.
| Device ID | K853760 |
| 510k Number | K853760 |
| Device Name: | ADULT VENTILATOR TESTER VT-1 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BIO-TEK INSTRUMENTS, INC. ONE MILL ST. Burlington, VT 05401 |
| Contact | David W Klyszeiko |
| Correspondent | David W Klyszeiko BIO-TEK INSTRUMENTS, INC. ONE MILL ST. Burlington, VT 05401 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1985-12-03 |