SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES— 510(k) K950464

Name: FDA 510(k) clearance K950464
Creator: U.S. Food and Drug Administration
Published: 1995-04-25

Substantially Equivalent

Sscor

FDA 510(k) clearance K950464 for SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES, Substantially Equivalent on 1995-04-25. Applicant: Sscor. Device class: 2.

Clearance details

Applicant: Sscor
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1995-02-03
Decision date: 1995-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sun Valley, CA, US

Download summary PDF View on FDA.gov ↗

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K972074 — SUCTION INSTRUMENTATION1997-07-25
K971022 — CHASE SUCKER1997-04-17
K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE1996-12-31

More clearances from Sscor

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K041154 — S-SCORT...JR QUICKDRAW, MODEL 24002004-05-18
K964997 — S-SCORT (2500)1997-03-05
K952632 — S-SCORT1995-06-16
K945929 — S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP1994-12-22

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.