The following data is part of a premarket notification filed by Clinicomp, Inc. with the FDA for Clinical Infor Syst(cis) W/fetal Monit Remote Disp.
| Device ID | K931133 |
| 510k Number | K931133 |
| Device Name: | CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP |
| Classification | System, Monitoring, Perinatal |
| Applicant | CLINICOMP, INC. 9655 TOWNE CENTRE DR. San Diego, CA 92121 |
| Contact | Chris Haudenschild |
| Correspondent | Chris Haudenschild CLINICOMP, INC. 9655 TOWNE CENTRE DR. San Diego, CA 92121 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-05 |
| Decision Date | 1995-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B321600226100010 | K931133 | 000 |
| B321600226110010 | K931133 | 000 |
| B321600226110 | K931133 | 000 |
| B321598226010 | K931133 | 000 |
| B32160022611 | K931133 | 000 |
| B32159822601 | K931133 | 000 |
| B32160022611001 | K931133 | 000 |
| B321598107300 | K931133 | 000 |
| B321598221010020 | K931133 | 000 |
| B321598223010 | K931133 | 000 |
| B321598223020 | K931133 | 000 |
| B321598225010 | K931133 | 000 |
| B321598226000 | K931133 | 000 |
| B321600225000 | K931133 | 000 |
| B321600225000010 | K931133 | 000 |
| B321600226000 | K931133 | 000 |
| B321600226000010 | K931133 | 000 |
| B321600226100 | K931133 | 000 |
| B321340226010 | K931133 | 000 |