Aerochamber

FDA 510(k) K872037 · Monaghan Medical Corp.

Substantially Equivalent

510(k) numberK872037

Submission

Device name
Aerochamber
Applicant
Monaghan Medical Corp.
Plattsburgh, NY, US
Received
May 27, 1987
Decision date
July 24, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYP – Mouthpiece, Breathing
Device class
Class I (low risk)
Regulation
21 CFR 868.5620
Specialty
Anesthesiology

Other 510(k)s with product code BYP

510(k)DeviceApplicantDecision
K955657North State Plastics Respiratory MouthpieceBYP · Traditional North State Plastics, Inc.03/12/1996SE
K944512Truzone PFM Disposable MouthpieceBYP · Traditional Monaghan Medical Corp.11/02/1994SE
K893791Breathing MouthpieceBYP · Traditional Diemolding Corp.06/23/1989SE
K865093Safe-T-Shield MouthpieceBYP · Traditional Medi Nuclear Corp., Inc.01/15/1987SE
K863049Inhalation AidBYP · Traditional Boehringer Ingelheim Pharmaceuticals, Inc.10/15/1986SE
K862788MP-4400 Mouthpiece-Flange SealBYP · Traditional Medipart Jerry Alexander08/01/1986SE
K853575Medipart Mouthpiece MP-1010BYP · Traditional Medipart Jerry Alexander10/29/1985SE
K853574Medipart Dispos. Mouthpiece W/22MM O.D. MP-4411BYP · Traditional Medipart Jerry Alexander10/29/1985SE
K853572Medipart Dispos. Mouthpiece W/2MM I.D. MP-4410BYP · Traditional Medipart Jerry Alexander10/29/1985SE
K853266Plastic Mouth Barrier Hsv-IBYP · Traditional Westmark Enterprises, Inc.10/29/1985SE

More from Westmark Enterprises, Inc.

510(k)DeviceDecision
K220145Monaghan medical filtered mouthpiece kitCAF · Traditional 08/24/2023SE
K123945Strive Dual Zone Peak Flow MeterBZH · Traditional 04/17/2013SE
K110273Aerovent Plus CHCCAF · Traditional 06/09/2011SE
K031514Modification to Trupeak Peak Flow MeterBZH · Special 05/23/2003SE
K023097Truezone Peak Flow MeterBZH · Abbreviated 03/07/2003SE
K012939Aerovent II CHC Collapsible Holding ChamberCAF · Special 09/28/2001SE
K991212Modification to Truzone Peak Flow MeterBZH · Abbreviated 07/01/1999SE
K964130Aerogear Asthma Action KitBZH · Traditional 01/10/1997SE
K963089Truzone Peak Flow MeterBZH · Traditional 11/06/1996SE
K963095Trupeak Peak Flow MeterBZH · Traditional 11/04/1996SE

Questions and answers

When was Aerochamber cleared by the FDA?

Aerochamber (K872037) received a 510(k) decision of Substantially Equivalent on July 24, 1987, 58 days after the submission was received.

What is the product code of K872037?

The FDA product code is BYP – Mouthpiece, Breathing, a Class I (low risk) device regulated under 21 CFR 868.5620.