510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K771685Substantially Equivalent

Amplifier Model N5a-His

Honeywell, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771685 is the FDA 510(k) clearance record for AMPLIFIER MODEL N5A-HIS, a class I device, cleared for Honeywell, Inc. on under FDA product code DRJ (System, Signal Isolation). FDA records list 69 510(k) clearances for Honeywell, Inc., from to . As of , FDA records show no recalls naming K771685.

Clearance record

Decision date
Received
(8 days to decision)
Product code
DRJ System, Signal Isolation
Regulation
21 CFR 870.2600
Device class
Class I
Review panel
Cardiovascular
Applicant
Honeywell, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DRJ

Trailing 12 months

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

FDA records show no clearances under product code DRJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRJ, 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