Bag, Post Operative Lung Exercizing Blow

FDA 510(k) K760167 · Dytek Corp.

Substantially Equivalent

510(k) numberK760167

Submission

Device name
Bag, Post Operative Lung Exercizing Blow
Applicant
Dytek Corp.
Mchenry, IL, US
Received
July 6, 1976
Decision date
August 6, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BWF – Spirometer, Therapeutic (Incentive)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5690
Specialty
Anesthesiology

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K222018Breathe+BWF · Traditional Peep Medical, LLC Dba Go2 Devices06/02/2023SE
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K192000D R Burton OxyPAPBWF · Traditional D R Burton Healthcare, LLC02/19/2020SE
K181660Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional Smiths Medical10/24/2019SE
K183108Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional Trudell Medical International08/16/2019SE
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More from Teleflexmedical, Inc.

510(k)DeviceDecision
K781245Lung Exer. Bag, Post-Op, ModifiedBWF · Traditional 09/20/1978SE
K760168Pencil, ElectrosurgicalGEI · Traditional 08/09/1976SE

Questions and answers

When was Bag, Post Operative Lung Exercizing Blow cleared by the FDA?

Bag, Post Operative Lung Exercizing Blow (K760167) received a 510(k) decision of Substantially Equivalent on August 6, 1976, 31 days after the submission was received.

What is the product code of K760167?

The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.