TRUZONE PFM DISPOSABLE MOUTHPIECE— 510(k) K944512

Name: FDA 510(k) clearance K944512
Creator: U.S. Food and Drug Administration
Published: 1994-11-02

Substantially Equivalent

Monaghan Medical Corp.

FDA 510(k) clearance K944512 for TRUZONE PFM DISPOSABLE MOUTHPIECE, Substantially Equivalent on 1994-11-02. Applicant: Monaghan Medical Corp.. Device class: 1.

Clearance details

Applicant: Monaghan Medical Corp.
Product code: Code BYP
Device class: Class 1
Regulation: 21 CFR 868.5620
Advisory panel: Anesthesiology
Date received: 1994-09-15
Decision date: 1994-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plattsburgh, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYP

view all

K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE1996-03-12
K893791 — BREATHING MOUTHPIECE1989-06-23
K872037 — AEROCHAMBER1987-07-24
K865093 — SAFE-T-SHIELD MOUTHPIECE1987-01-15
K863049 — INHALATION AID1986-10-15

More clearances from Monaghan Medical Corp.

view all

K123945 — STRIVE DUAL ZONE PEAK FLOW METER2013-04-17
K031514 — MODIFICATION TO TRUPEAK PEAK FLOW METER2003-05-23
K023097 — TRUEZONE PEAK FLOW METER2003-03-07
K012939 — AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER2001-09-28
K991212 — MODIFICATION TO TRUZONE PEAK FLOW METER1999-07-01

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