The following data is part of a premarket notification filed by International Biomedics, Inc. with the FDA for Air-cushion Tocotonometer.
| Device ID | K860933 |
| 510k Number | K860933 |
| Device Name: | AIR-CUSHION TOCOTONOMETER |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell, WA 98021 |
| Contact | Howard M Hochberg |
| Correspondent | Howard M Hochberg INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell, WA 98021 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-12 |
| Decision Date | 1986-07-09 |