510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K883297Substantially Equivalent

Hewlett-Packard Modles 78354A/78352 Pulse Oximeter

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

K883297 is the FDA 510(k) clearance record for HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER, a class II device, cleared for Hewlett-Packard Co. on under FDA product code DQA (Oximeter). FDA records list 246 510(k) clearances for Hewlett-Packard Co., from to . As of , FDA records show no recalls naming K883297.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Hewlett-Packard Co. 175 Wyman St., Waltham MA
Third party review
No

Clearances, product code DQA

Trailing 12 months
13 clearances under product code DQA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
November 20252
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261