ULTRASOUND TRANSDUCER DRAPE— 510(k) K970889

Name: FDA 510(k) clearance K970889
Creator: U.S. Food and Drug Administration
Published: 1997-10-20

Substantially Equivalent

Protek Medical Products, Inc.

FDA 510(k) clearance K970889 for ULTRASOUND TRANSDUCER DRAPE, Substantially Equivalent on 1997-10-20. Applicant: Protek Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Protek Medical Products, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1997-03-11
Decision date: 1997-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iowa City, IA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

view all

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II2023-10-25
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from Protek Medical Products, Inc.

view all

K973958 — GENERAL PURPOSE ATL NEEDLE GUIDE KIT1998-01-22
K973622 — TRANSDUCER POSITIONER1997-11-26
K970893 — ULTRASOUND TRANSDUCER DRAPE1997-10-20
K973362 — NEEDLE GUIDE/GRID1997-10-01
K970885 — ULTRASOUND SYSTEMS DRAPE1997-09-22

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