INCENTIVE SPIROMETER

Spirometer, Therapeutic (incentive)

I-SPIRON

The following data is part of a premarket notification filed by I-spiron with the FDA for Incentive Spirometer.

Pre-market Notification Details

• Device ID: K760762
• 510k Number: K760762
• Device Name: INCENTIVE SPIROMETER
• Classification: Spirometer, Therapeutic (incentive)
• Applicant: I-SPIRON 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: BWF
• CFR Regulation Number: 868.5690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1976-10-04
• Decision Date: 1976-10-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30351688404002	K760762	000