The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Birthnet Ii Perinatal Patient Data Management System.
| Device ID | K965008 |
| 510k Number | K965008 |
| Device Name: | BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM |
| Classification | System, Monitoring, Perinatal |
| Applicant | SPACELABS MEDICAL, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Contact | Anthony Calderoni |
| Correspondent | Anthony Calderoni SPACELABS MEDICAL, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-16 |
| Decision Date | 1997-12-16 |
| Summary: | summary |