The following data is part of a premarket notification filed by Peritronics Research And Development, Inc. with the FDA for Perinatal Computer Sys Model 100a & 100b.
| Device ID | K855044 |
| 510k Number | K855044 |
| Device Name: | PERINATAL COMPUTER SYS MODEL 100A & 100B |
| Classification | System, Monitoring, Perinatal |
| Applicant | PERITRONICS RESEARCH AND DEVELOPMENT, INC. P.O. BOX 1117 Arcadia, CA 91006 |
| Contact | Seng Koh |
| Correspondent | Seng Koh PERITRONICS RESEARCH AND DEVELOPMENT, INC. P.O. BOX 1117 Arcadia, CA 91006 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-17 |
| Decision Date | 1986-03-12 |