510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915848Substantially Equivalent

Sensormedics Model 2450 Pulmonary Function Lab.

Sensor Medics Corp., Yorba Linda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915848 is the FDA 510(k) clearance record for SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB., a class II device, cleared for Sensor Medics Corp. on under FDA product code DZJ (Driver, Wire, And Bone Drill, Manual). FDA records list 26 510(k) clearances for Sensor Medics Corp., from to . As of , FDA records show no recalls naming K915848.

Clearance record

Decision date
Received
(307 days to decision)
Product code
DZJ Driver, Wire, And Bone Drill, Manual
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Sensor Medics Corp. 22705 Savi Ranch Pkwy., Yorba Linda CA
510(k) summary
Summary
Third party review
No

Clearances, product code DZJ

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