ORBIT

Spirometer, Diagnostic

NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC

The following data is part of a premarket notification filed by National Biomedical Llc Dba Qrs Diagnostic with the FDA for Orbit.

Pre-market Notification Details

• Device ID: K120880
• 510k Number: K120880
• Device Name: ORBIT
• Classification: Spirometer, Diagnostic
• Applicant: NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC 6901 E. Fish Lake Road Suite 188 Maple Grove, MN 55369
• Contact: Mary Kay Jensen
• Correspondent: Mary Kay Jensen; NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC 6901 E. Fish Lake Road Suite 188 Maple Grove, MN 55369
• Product Code: BZG
• CFR Regulation Number: 868.1840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-23
• Decision Date: 2012-04-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857175006050	K120880	000