SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT— 510(k) K962931
Substantially EquivalentSmiths Industries Medical Systems, Inc.
FDA 510(k) clearance K962931 for SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT, Substantially Equivalent on 1996-10-21. Applicant: Smiths Industries Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Industries Medical Systems, Inc.
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keene, NH, US
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More clearances from Smiths Industries Medical Systems, Inc.
view all- K972385 — FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
- K965017 — REGIONAL ANESTHESIA TRAYS
- K962175 — PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
- K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
- K960429 — PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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.