PHYSIOLOGICAL MONITOR 2100— 510(k) K844353
Substantially EquivalentDatascope Corp.
FDA 510(k) clearance K844353 for PHYSIOLOGICAL MONITOR 2100, Substantially Equivalent on 1985-04-01. Applicant: Datascope Corp.. Device class: 2.
Clearance details
- Applicant
- Datascope Corp.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paramus, NJ, US
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More clearances from Datascope Corp.
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- K181122 — CARDIOSAVE Intra-Aortic Balloon Pump
- K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
- K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
- K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.