510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133064Substantially Equivalent

Mysign S Pulse Oximeter, Mysign Pc Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31

Envitec-Wismar GmbH, Egale WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133064 is the FDA 510(k) clearance record for MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31, a class II device, cleared for Envitec-Wismar GmbH on under FDA product code DQA (Oximeter). FDA records list 9 510(k) clearances for Envitec-Wismar GmbH, from to . As of , FDA records show no recalls naming K133064.

Clearance record

Decision date
Received
(217 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Envitec-Wismar GmbH S65w35739 Piper Rd., Egale WI
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