510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897107Substantially Equivalent

Poly G Physiological Data Recorder

Cns, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897107 is the FDA 510(k) clearance record for POLY G PHYSIOLOGICAL DATA RECORDER, a class I device, cleared for Cns, Inc. on under FDA product code BXO (Transducer, Gas Pressure). FDA records list 7 510(k) clearances for Cns, Inc., from to . As of , FDA records show no recalls naming K897107.

Clearance record

Decision date
Received
(81 days to decision)
Product code
BXO Transducer, Gas Pressure
Regulation
21 CFR 868.2900
Device class
Class I
Review panel
Anesthesiology
Applicant
Cns, Inc. 7090 Shady Oak Rd., Eden Prairie MN
Third party review
No

Clearances, product code BXO

Trailing 12 months

FDA records hold no clearances under product code BXO in the trailing twelve months.

FDA records show no clearances under product code BXO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BXO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260