510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162580Substantially Equivalent

Guardian Angel GA1000 Digital Vital Sign Monitoring System

Taiwan Aulisa Medical Devices Technologies, Inc., Taipei, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162580 is the FDA 510(k) clearance record for Guardian Angel GA1000 Digital Vital Sign Monitoring System, a class II device, cleared for Taiwan Aulisa Medical Devices Technologies, Inc. on under FDA product code DQA (Oximeter). FDA records list 9 510(k) clearances for Taiwan Aulisa Medical Devices Technologies, Inc., from to . As of , FDA records show no recalls naming K162580.

Clearance record

Decision date
Received
(169 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Taiwan Aulisa Medical Devices Technologies, Inc. Rm. 1052, Bldg. H, 10f., # 3-2, Yuanqu St.,, Taipei, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQA

Trailing 12 months
12 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 20260