DISPOSABLE MOUTHPIECE— 510(k) K791537

Substantially Equivalent

Hospitak, Inc.

FDA 510(k) clearance K791537 for DISPOSABLE MOUTHPIECE, Substantially Equivalent on 1979-09-07. Applicant: Hospitak, Inc.. Device class: 1.

Clearance details

Applicant: Hospitak, Inc.
Product code: Code BYP
Device class: Class 1
Regulation: 21 CFR 868.5620
Advisory panel: Anesthesiology
Date received: 1979-08-10
Decision date: 1979-09-07
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 Hospitak, Inc.

K955483 — TRACH MASK MODEL (245, 246)1996-02-28
K954787 — ILLUMINATOR1996-01-31
K953619 — WARM N WET HME W/LUER ADAPTER1995-08-25
K953620 — WARM N WET HMEF W/LUER ADAPTER1995-08-25
K915750 — DISPOSABLE BACTERIAL BREATHNG FILTER1994-11-30

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