510(k) K102422 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SPACELABS MEDICAL PATIENT MONITORS
| Applicant | Spacelabs Medical, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Dec 7, 2010 |
| Received | Aug 25, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102422
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2014 | Spacelabs Healthcare Inc Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option Terminated |
MHX | None listed |
| Aug 17, 2011 | Spacelabs Healthcare, Llc Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, & 91393 are sold with with Perioperative Mode (op Terminated |
MHX | None listed |
| May 3, 2011 | Spacelabs Healthcare, Llc Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496.
Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-0 Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.