The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Series 1000.
| Device ID | K760612 |
| 510k Number | K760612 |
| Device Name: | SPACELABS SERIES 1000 |
| Classification | Electrocardiograph |
| Applicant | SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-10 |
| Decision Date | 1976-09-21 |