CRYSTAL MASK— 510(k) K870206

Substantially Equivalent

Brunswick Mfg. Co., Inc.

FDA 510(k) clearance K870206 for CRYSTAL MASK, Substantially Equivalent on 1987-02-20. Applicant: Brunswick Mfg. Co., Inc.. Device class: 1.

Clearance details

Applicant: Brunswick Mfg. Co., Inc.
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1987-01-20
Decision date: 1987-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Quincy, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYG

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K962848 — HANS RUDOLPH NASAL CPAP MASK1996-10-16
K945482 — DISPOSABLE, CPAP OXYGEN MASK1995-09-19
K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK1995-09-18
K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS1995-09-15

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