The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Pr4.
| Device ID | K911097 |
| 510k Number | K911097 |
| Device Name: | PR4 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | MORTARA INSTRUMENT, INC. 181 CEDAR HILL RD. Marlboro, MA 01752 |
| Contact | Rodney Cambre |
| Correspondent | Rodney Cambre MORTARA INSTRUMENT, INC. 181 CEDAR HILL RD. Marlboro, MA 01752 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-12 |
| Decision Date | 1991-08-07 |