Home / 510(k) Clearances / K970885

510(k) K970885

ULTRASOUND SYSTEMS DRAPE by Protek Medical Products, Inc. — Product Code MMP

K970885 is an FDA 510(k) premarket notification submitted by Protek Medical Products, Inc. for the device "ULTRASOUND SYSTEMS DRAPE". The FDA issued a decision of Substantially Equivalent on September 22, 1997. The device falls under product code MMP (Cover, Barrier, Protective), a Class II device regulated under 21 CFR 878.4370. Protek Medical Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1997
Date Received
March 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Barrier, Protective
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Protek Medical Products, Inc.

  • K973958 — GENERAL PURPOSE ATL NEEDLE GUIDE KIT (January 22, 1998)
  • K973622 — TRANSDUCER POSITIONER (November 26, 1997)
  • K970889 — ULTRASOUND TRANSDUCER DRAPE (October 20, 1997)
  • K970893 — ULTRASOUND TRANSDUCER DRAPE (October 20, 1997)
  • K973362 — NEEDLE GUIDE/GRID (October 1, 1997)
  • K970891 — DRAPE, SURGICAL-LATEX (August 22, 1997)
  • K971722 — TRANS VAGINAL NEEDLE GUIDE (July 10, 1997)
  • K971115 — GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE (June 13, 1997)

Other clearances for product code MMP

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K043234 — LIGHT DRAPE (May 25, 2005)
  • K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (November 30, 2004)
  • K040794 — INCUBATOR CAPE (June 10, 2004)
  • K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERS (September 22, 2003)
  • K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (February 4, 2003)
  • K014239 — MEDSURG EQUIPMENT COVERS (February 19, 2002)
  • K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (January 30, 1997)
  • K961699 — EQUIPMENT COVERS (August 23, 1996)
  • K952241 — PROTOUCH OVERGLOVE (August 7, 1995)

FDA data resources