MOUTHPIECE SEAL— 510(k) K761297

Substantially Equivalent

Oem Medical Div.

FDA 510(k) clearance K761297 for MOUTHPIECE SEAL, Substantially Equivalent on 1977-01-03. Applicant: Oem Medical Div.. Device class: 1.

Clearance details

Applicant: Oem Medical Div.
Product code: Code BYP
Device class: Class 1
Regulation: 21 CFR 868.5620
Advisory panel: Anesthesiology
Date received: 1976-12-21
Decision date: 1977-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYP

K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE1996-03-12
K944512 — TRUZONE PFM DISPOSABLE MOUTHPIECE1994-11-02
K893791 — BREATHING MOUTHPIECE1989-06-23
K872037 — AEROCHAMBER1987-07-24
K865093 — SAFE-T-SHIELD MOUTHPIECE1987-01-15

More clearances from Oem Medical Div.

K924570 — OEM MULTI-VAC POWERED SUCTION PUMP1993-08-05
K925893 — OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT1993-03-12
K922748 — GUEDEL AIRWAY1992-07-10
K811855 — SKIN SCRUB KITS1981-07-31

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