510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903618Substantially Equivalent

Robertazzi Nasopharyngeal Airway

Eastmed Enterprises, Inc., Marlton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903618 is the FDA 510(k) clearance record for ROBERTAZZI NASOPHARYNGEAL AIRWAY, a class I device, cleared for Eastmed Enterprises, Inc. on under FDA product code BTQ (Airway, Nasopharyngeal). FDA records list 13 510(k) clearances for Eastmed Enterprises, Inc., from to . As of , FDA records show no recalls naming K903618.

Clearance record

Decision date
Received
(154 days to decision)
Product code
BTQ Airway, Nasopharyngeal
Regulation
21 CFR 868.5100
Device class
Class I
Review panel
Anesthesiology
Applicant
Eastmed Enterprises, Inc. 5 Pembury Ct., Marlton NJ
Third party review
No

Clearances, product code BTQ

Trailing 12 months

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

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