510(k) K883899

Device
MANUAL PERCUSSOR CUPS
Applicant
MEDICAL COMPONENTS, INC.
510(k) number
K883899
Product code
BYI  
Decision
Substantially Equivalent (SESE)
Decision date
1988-12-13
Date received
1988-09-15
Regulation
868.5665
Classification name
Percussor, Powered-electric
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DUNCAN G JOHNSON
Address
411 Fremont St. Anoka MN US 55303 55303

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252849AffloVest® Mobile Airway Clearance TherapyTactile Medical2026-04-30
K250860BreatheBand® (Model 1000)Exemplar Medical, LLC2025-10-02
K242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.2024-12-19
K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.2024-12-18
K233441The Vest APX System (PVAPX1)Baxter Healthcare Corportation2024-03-22
K222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.2022-11-18
K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc.2021-02-12
K203209AirPhysio Positive Expiratory Pressure (PEP) DeviceAirphysio Pty, Ltd.2021-01-15
K173603Monarch Airway Clearance SystemHill-Rom Holdings, Inc.2018-10-24
K163378Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd.2017-03-17
K142482The Vest Airway Clearance SystemHill-Rom Services Private Limited2015-05-07
K132794SMARTVEST AIRWAY CLEARANCE SYSTEMElectromed, Inc.2013-12-19
K121587BREATH SHAKECheen Houng Ent. Co. , Ltd.2013-11-22
K122480INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVESTInternational Biophysics Corporation2013-03-27
K121170RESIN 11Respinnovation Sas2012-07-13

Legacy Summary#

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FDA Review#

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