BREATHING BAGS— 510(k) K932584

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K932584 for BREATHING BAGS, Substantially Equivalent on 1993-07-16. Applicant: Merit Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code BTC
Device class: Class 1
Regulation: 21 CFR 868.5320
Advisory panel: Anesthesiology
Date received: 1993-05-27
Decision date: 1993-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTC

K181424 — PeDIA2018-09-25
K940220 — REBREATHER BAGS1994-05-27
K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS1993-07-16
K932581 — BREATHING BAGS1993-07-16
K932191 — BREATHING BAGS1993-07-02

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