PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY— 510(k) K850263

Name: FDA 510(k) clearance K850263
Creator: U.S. Food and Drug Administration
Published: 1985-03-25

Substantially Equivalent

Plasmedics, Inc.

FDA 510(k) clearance K850263 for PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY, Substantially Equivalent on 1985-03-25. Applicant: Plasmedics, Inc.. Device class: 1.

Clearance details

Applicant: Plasmedics, Inc.
Product code: Code BSJ
Device class: Class 1
Regulation: 21 CFR 868.5550
Advisory panel: Anesthesiology
Date received: 1985-01-23
Decision date: 1985-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashland, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSJ

view all

K163277 — SuperNO2VA Device2017-10-13
K953107 — ANESTHESIA/RESPIRATORY FACE MASK1995-08-15
K953295 — ANESTHESIA FACE MASK1995-08-11
K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK1995-07-11
K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK1995-06-07

More clearances from Plasmedics, Inc.

view all

K853559 — STERILE BIOPSY NEEDLES1985-09-11
K831601 — APNEA ALARM FOR ADULT-PEDIATRIC & NEON1983-09-26
K831650 — ANESTHESIA/RESPIRATORY DISCONNECT -1983-09-12
K830604 — WEDGE PRESSURE CATHETER1983-07-18
K823351 — CENTRAL VENOUS CATHETER1982-12-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.