The following data is part of a premarket notification filed by Base Ten Systems, Inc. with the FDA for Prenval I.
| Device ID | K953652 |
| 510k Number | K953652 |
| Device Name: | PRENVAL I |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | BASE TEN SYSTEMS, INC. ONE ELECTTONICS DR. P.O. BOX 3151 TRENTON, NJ 08619 |
| Contact | RICHARD J FARRELLY |
| Correspondent | RICHARD J FARRELLY BASE TEN SYSTEMS, INC. ONE ELECTTONICS DR. P.O. BOX 3151 TRENTON, NJ 08619 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1995-09-15 |