The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Spacelbs Model On Trak (90227) Ambulatory Bloody Pressure (abp) Non-invasive.
| Device ID | K141113 |
| 510k Number | K141113 |
| Device Name: | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland, CO 80466 |
| Contact | Al Van Houdt |
| Correspondent | Al Van Houdt SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland, CO 80466 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-30 |
| Decision Date | 2014-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522129254 | K141113 | 000 |
| 10841522102233 | K141113 | 000 |
| 10841522102240 | K141113 | 000 |
| 10841522102257 | K141113 | 000 |
| 10841522102530 | K141113 | 000 |
| 10841522102547 | K141113 | 000 |
| 10841522105074 | K141113 | 000 |
| 10841522107719 | K141113 | 000 |
| 10841522123177 | K141113 | 000 |
| 10841522123337 | K141113 | 000 |
| 10841522123344 | K141113 | 000 |
| 10841522123351 | K141113 | 000 |
| 10841522123368 | K141113 | 000 |
| 10841522123375 | K141113 | 000 |
| 10841522126864 | K141113 | 000 |
| 10841522129223 | K141113 | 000 |
| 10841522129230 | K141113 | 000 |
| 10841522128790 | K141113 | 000 |