The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Nightwatch(tm) System.
| Device ID | K870578 |
| 510k Number | K870578 |
| Device Name: | NIGHTWATCH(TM) SYSTEM |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-10 |
| Decision Date | 1987-06-29 |