510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946322Substantially Equivalent

Polygram Software

Synectics Medical, Inc., S-116 28 Stockholm, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946322 is the FDA 510(k) clearance record for POLYGRAM SOFTWARE, a class II device, cleared for Synectics Medical, Inc. on under FDA product code BZG (Spirometer, Diagnostic). FDA records list 5 510(k) clearances for Synectics Medical, Inc., from to . As of , FDA records show no recalls naming K946322.

Clearance record

Decision date
Received
(191 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Synectics Medical, Inc. Renstienas Gata 12, 5tr., S-116 28 Stockholm, SE
510(k) summary
Statement
Third party review
No

Clearances, product code BZG

Trailing 12 months
1 clearance under product code BZG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260