The following data is part of a premarket notification filed by Createch Corp. with the FDA for Knightwatch System.
| Device ID | K896934 |
| 510k Number | K896934 |
| Device Name: | KNIGHTWATCH SYSTEM |
| Classification | Monitor, Breathing Frequency |
| Applicant | CREATECH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Stephen Lawrence |
| Correspondent | Stephen Lawrence CREATECH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-13 |
| Decision Date | 1990-06-25 |