SEALFLEX MASK— 510(k) K874746

Substantially Equivalent

Engineered Medical Systems

FDA 510(k) clearance K874746 for SEALFLEX MASK, Substantially Equivalent on 1987-12-21. Applicant: Engineered Medical Systems. Device class: 1.

Clearance details

Applicant: Engineered Medical Systems
Product code: Code BSJ
Device class: Class 1
Regulation: 21 CFR 868.5550
Advisory panel: Anesthesiology
Date received: 1987-11-18
Decision date: 1987-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSJ

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 Engineered Medical Systems

K023683 — MULTI-STRAP FULL FACE MASK2003-12-01
K013728 — TRACH VOX2002-07-30
K013122 — EMS ELECTROSTATIC FLITER AND HME COMBINATION2002-04-19
K013089 — EMS HEPA FILTER AND HME COMBINATIONS2002-03-14
K013123 — EMS PULMONARY FUNCTION TESTING FILTER2002-03-14

Recalls naming K874746

K-number listed on FDA's recall record

Z-1058-2013 — Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .Class I·Terminated·Engineered Medical Systems,Inc·20110912

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K874746.

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