MICRO-TEMP PUMPS & MICRO-TEMP PADS— 510(k) K843146

Name: FDA 510(k) clearance K843146
Creator: U.S. Food and Drug Administration
Published: 1984-08-17

Substantially Equivalent

Seabrook Medical Systems, Inc.

FDA 510(k) clearance K843146 for MICRO-TEMP PUMPS & MICRO-TEMP PADS, Substantially Equivalent on 1984-08-17. Applicant: Seabrook Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Seabrook Medical Systems, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1984-08-10
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K843146

K-number listed on FDA's recall record

Z-1129-2015 — Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.Class II·Terminated·Cincinnati Sub-Zero Products Inc·20150107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K843146.

Data sourced from openFDA. This site is unofficial and independent of the FDA.