STRAP, HEAD, GAS MASK— 510(k) K914335

Substantially Equivalent

Vital Signs, Inc.

FDA 510(k) clearance K914335 for STRAP, HEAD, GAS MASK, Substantially Equivalent on 1992-04-02. Applicant: Vital Signs, Inc.. Device class: 1.

Clearance details

Applicant: Vital Signs, Inc.
Product code: Code BTK
Device class: Class 1
Regulation: 21 CFR 868.5560
Advisory panel: Anesthesiology
Date received: 1991-09-27
Decision date: 1992-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Totowa, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTK

K944949 — GENERAL ANESTHESIA SYSTEM1994-11-14
K854537 — HEADSTRAP1985-12-03
K853573 — MEDIPART FACE MASK HEADSTRAP MP-91001985-10-29
K831008 — HEAD STRAP1983-05-09
K810991 — HEADSTRAP1981-04-29

More clearances from Vital Signs, Inc.

K112902 — ENFLOW IV FLUID WARMER2012-03-14
K041309 — IMASK TM2004-06-30
K030985 — BREAS PV 10I CPAP SYSTEM, MODEL PV 10I2003-10-15
K022402 — DISPOSABLE PRESSURE MANOMETER2002-08-22
K021315 — SURE-LOK2002-08-21

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