The following data is part of a premarket notification filed by Tokos Medical Corp. with the FDA for Term Guard Ii Device.
| Device ID | K893770 |
| 510k Number | K893770 |
| Device Name: | TERM GUARD II DEVICE |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | TOKOS MEDICAL CORP. 1821 EAST DYER RD. SUITE 200 Santa Ana, CA 92705 |
| Contact | Penni Pannell |
| Correspondent | Penni Pannell TOKOS MEDICAL CORP. 1821 EAST DYER RD. SUITE 200 Santa Ana, CA 92705 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-22 |
| Decision Date | 1989-11-03 |