PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE

Spirometer, Therapeutic (incentive)

HEALTHSCAN PRODUCTS, INC.

The following data is part of a premarket notification filed by Healthscan Products, Inc. with the FDA for Pep (positive Expiratory Pressure) Therapy Device.

Pre-market Notification Details

• Device ID: K961077
• 510k Number: K961077
• Device Name: PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
• Classification: Spirometer, Therapeutic (incentive)
• Applicant: HEALTHSCAN PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 -1292
• Contact: Lauren R Ziegler
• Correspondent: Lauren R Ziegler; HEALTHSCAN PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 -1292
• Product Code: BWF
• CFR Regulation Number: 868.5690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-03-18
• Decision Date: 1996-07-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00383730001043	K961077	000
00383730001036	K961077	000
00383730000138	K961077	000