510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934439Substantially Equivalent

Rechargeable Battery Pack for Critikon 8100 Vital Signs Monitor

Portable Power Systems, Inc., Parker CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934439 is the FDA 510(k) clearance record for RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR, a class II device, cleared for Portable Power Systems, Inc. on under FDA product code DPS (Electrocardiograph). FDA records list 18 510(k) clearances for Portable Power Systems, Inc., from to . As of , FDA records show no recalls naming K934439.

Clearance record

Decision date
Received
(178 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Portable Power Systems, Inc. 10336 S. Dransfeldt Rd., Parker CO
510(k) summary
Statement
Third party review
No

Clearances, product code DPS

Trailing 12 months
5 clearances under product code DPS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260