510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233501Substantially Equivalent

“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)

Largan Medical Co., Ltd., Taichung, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233501 is the FDA 510(k) clearance record for “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A), a class II device, cleared for Largan Medical Co., Ltd. on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list 8 510(k) clearances for Largan Medical Co., Ltd., from to . As of , FDA records show no recalls naming K233501.

Clearance record

Decision date
Received
(269 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Largan Medical Co., Ltd. 2f., # 14. 23rd., Taichung Industrial Park, Nantun Dist.,, Taichung, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNR

Trailing 12 months
6 clearances under product code MNR in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MNR, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20260
September 20261
October 20260