510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K896030Substantially Equivalent

Hewlett-Packard Model M1016a CO2 & M1017a Fi02

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

K896030 is the FDA 510(k) clearance record for HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02, a class II device, cleared for Hewlett-Packard Co. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K896030.

Clearance record

Decision date
Received
(66 days to decision)
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation
21 CFR 868.1400
Device class
Class II
Review panel
Anesthesiology
Applicant
Hewlett-Packard Co. 175 Waltham St., Waltham MA
Third party review
No

Clearances, product code CCK

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