The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace(r) Disposable Tocotonometer.
| Device ID | K910282 |
| 510k Number | K910282 |
| Device Name: | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Contact | Van Dine |
| Correspondent | Van Dine GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-23 |
| Decision Date | 1991-03-29 |