CARDIOCALL CARDIAC EVENT RECORDER— 510(k) K972649
Substantially EquivalentReynolds Medical , Ltd.
FDA 510(k) clearance K972649 for CARDIOCALL CARDIAC EVENT RECORDER, Substantially Equivalent on 1997-12-04. Applicant: Reynolds Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Reynolds Medical , Ltd.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hasbrouck, NJ, US
Recent devices under product code DXH
view allMore clearances from Reynolds Medical , Ltd.
view allRecalls naming K972649
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 K972649.
Data sourced from openFDA. This site is unofficial and independent of the FDA.