The following data is part of a premarket notification filed by Orion Industries with the FDA for Orion Watchguard.
| Device ID | K902104 |
| 510k Number | K902104 |
| Device Name: | ORION WATCHGUARD |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | ORION INDUSTRIES 12811 KENWOOD LANE, SUITE 203 Fort Myers, FL 33907 |
| Contact | Bob Grantham |
| Correspondent | Bob Grantham ORION INDUSTRIES 12811 KENWOOD LANE, SUITE 203 Fort Myers, FL 33907 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-08 |
| Decision Date | 1990-10-25 |