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510(k) K931604

3M MEDICAL DIAGNOSTIC VIDEOCASSETTE by 3M Health Care, Ltd. — Product Code IWZ

K931604 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "3M MEDICAL DIAGNOSTIC VIDEOCASSETTE". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1993
Date Received
April 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Film, Radiographic
Device Class
Class I
Regulation Number
892.1840
Review Panel
RA
Submission Type

Other clearances by 3M Health Care, Ltd.

  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K926364 — ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X (March 31, 1995)
  • K941534 — MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM (March 6, 1995)
  • K941748 — STERI-VAC GAS STERILIZER MODEL 8XL (December 2, 1994)
  • K930681 — 3M PREVENTION FABRIC SURGICAL GOWN #78XX (February 10, 1994)
  • K932307 — 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM (January 7, 1994)
  • K932422 — 3M TEGADERM HP TRANSPARENT DRESSING (December 27, 1993)
  • K932446 — INJECTION SITE (November 29, 1993)
  • K931968 — CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO (November 10, 1993)
  • K933005 — AVI MODEL 600 SYRINGE PUMP (October 25, 1993)

Other clearances for product code IWZ

  • K970154 — KODAK EKTASIAN HG FILM (EHG-15) (April 4, 1997)
  • K954200 — VOXGRAM (September 29, 1995)
  • K931605 — 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE (July 20, 1993)
  • K920539 — ORWO X-RAY FILM (June 30, 1992)
  • K884827 — KODAK DENTAL BARRIER PAC (January 30, 1989)
  • K862944 — KODAK CFT FILM SO-141 (August 12, 1986)
  • K862415 — TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (July 1, 1986)
  • K860797 — MEDICAL X-RAY FILM (March 13, 1986)
  • K844554 — BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG (February 21, 1985)
  • K840806 — FR MEDICAL X-RAY FILM (April 24, 1984)

FDA data resources