PERCEPTOR COMPENSATOR MORSE MANIFOLD— 510(k) K951722
Substantially EquivalentNamic
FDA 510(k) clearance K951722 for PERCEPTOR COMPENSATOR MORSE MANIFOLD, Substantially Equivalent on 1996-03-25. Applicant: Namic. Device class: 2.
Clearance details
- Applicant
- Namic
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Glens Falls, NY, US
Recent devices under product code DRS
view all- K254074 — TruPress
- K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
- K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
More clearances from Namic
view allAdverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
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.