SPACELABS MEDICAL PATIENT MONITORS— 510(k) K102422
Substantially EquivalentSpacelabs Medical, Inc.
FDA 510(k) clearance K102422 for SPACELABS MEDICAL PATIENT MONITORS, Substantially Equivalent on 2010-12-07. Applicant: Spacelabs Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Spacelabs Medical, Inc.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Issaquah, WA, US
Recent devices under product code MHX
view allMore clearances from Spacelabs Medical, Inc.
view all- K120616 — SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
- K112962 — SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
- K093501 — ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
- K082045 — MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
- K063490 — SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K102422
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102422.
Data sourced from openFDA. This site is unofficial and independent of the FDA.