The following data is part of a premarket notification filed by Biosys Co. Ltd. with the FDA for Biosys Fetal Monitor, Model Ifm-500.
| Device ID | K994008 |
| 510k Number | K994008 |
| Device Name: | BIOSYS FETAL MONITOR, MODEL IFM-500 |
| Classification | System, Monitoring, Perinatal |
| Applicant | BIOSYS CO. LTD. 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook BIOSYS CO. LTD. 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-09-29 |
| Summary: | summary |