510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K120880Substantially Equivalent

Orbit

National Biomedical, LLC dba Qrs Diagnostic, Maple Grove MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120880 is the FDA 510(k) clearance record for ORBIT, a class II device, cleared for National Biomedical, LLC Dba Qrs Diagnostic on under FDA product code BZG (Spirometer, Diagnostic). FDA records list one 510(k) clearance for National Biomedical, LLC Dba Qrs Diagnostic. As of , FDA records show no recalls naming K120880.

Clearance record

Decision date
Received
(27 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
National Biomedical, LLC Dba Qrs Diagnostic 6901 E. Fish Lake Rd., Suite 188, Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZG

Trailing 12 months
1 clearance under product code BZG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260