The following data is part of a premarket notification filed by Tokos Medical Corp. with the FDA for Term Guard 5000 Uterine Activity.
| Device ID | K843011 |
| 510k Number | K843011 |
| Device Name: | TERM GUARD 5000 UTERINE ACTIVITY |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | TOKOS MEDICAL CORP. 1200 18 ST. NW Washington , DC 20036 - |
| Contact | Steven A Heimberg |
| Correspondent | Steven A Heimberg TOKOS MEDICAL CORP. 1200 18 ST. NW Washington , DC 20036 - |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-31 |
| Decision Date | 1984-11-01 |