510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K883606Substantially Equivalent

Model Hp 15209A Trans. Combined Tcp02/tcpco2 Trans

Hewlett-Packard Co., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883606 is the FDA 510(k) clearance record for MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS, a class II device, cleared for Hewlett-Packard Co. on under FDA product code LKD (Monitor, Carbon-Dioxide, Cutaneous). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K883606.

Clearance record

Decision date
Received
(115 days to decision)
Product code
LKD Monitor, Carbon-Dioxide, Cutaneous
Regulation
21 CFR 868.2480
Device class
Class II
Review panel
Anesthesiology
Applicant
Hewlett-Packard Co. 175 Waltham St., Waltham MA
Third party review
No

Clearances, product code LKD

Trailing 12 months

FDA records hold no clearances under product code LKD in the trailing twelve months.

FDA records show no clearances under product code LKD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260