CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION— 510(k) K141582
Substantially EquivalentWelch Allyn
FDA 510(k) clearance K141582 for CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION, Substantially Equivalent on 2014-07-11. Applicant: Welch Allyn. Device class: 2.
Clearance details
- Applicant
- Welch Allyn
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Skaneateles Falls, NY, US
Recent devices under product code DPS
view allAdverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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 K141582
K-number listed on FDA's recall record- Z-1560-2025 — Welch Allyn CP150 Electrocardiograph:
- Z-2323-2024 — Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141582.
Data sourced from openFDA. This site is unofficial and independent of the FDA.