Home / 510(k) Clearances / K973162

510(k) K973162

DUAL RADIATION TARGETING SYSTEM DRTS DRAPE by Hogan & Hartson — Product Code IWE

K973162 is an FDA 510(k) premarket notification submitted by Hogan & Hartson for the device "DUAL RADIATION TARGETING SYSTEM DRTS DRAPE". The FDA issued a decision of Substantially Equivalent on November 20, 1997. The device falls under product code IWE (Monitor, Patient Position, Light-Beam), a Class I device regulated under 21 CFR 892.5780. Hogan & Hartson has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1997
Date Received
August 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
Review Panel
RA
Submission Type

Other clearances by Hogan & Hartson

  • K974168 — COOPERSURGICAL INFRARED COAGULATOR (January 23, 1998)
  • K973849 — BIOABSORBABLE BANKART TACK (January 6, 1998)
  • K950169 — RIBOSOMAL P EIA TEST SYSTEM (May 23, 1996)
  • K942389 — TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (February 16, 1996)
  • K946216 — CARDIOLIPIN A EIA TEST SYSTEM (January 24, 1996)
  • K946217 — CARDIOLIPIN M EIA TEST SYSTEM (January 24, 1996)
  • K946215 — CARDIOLIPIN G EIA TEST SYSTEM (January 24, 1996)
  • K946186 — CHAL-2500 (August 14, 1995)
  • K941566 — COMPUSPEAK (June 30, 1995)
  • K950110 — MARDX MITOCHONDRIA EIA TEST SYSTEM (May 15, 1995)

Other clearances for product code IWE

  • K152303 — CT Sim Laser System (September 11, 2015)
  • K955236 — GREEN TEC-2100 (May 24, 1996)
  • K954414 — CENTRALITE BACKPOINTER (October 23, 1995)
  • K950293 — TEC-2110 GREEN LASER MODEL MT-HNG (August 18, 1995)
  • K950112 — CENTRALITE(R)-DLL SERIES (August 16, 1995)
  • K951601 — MED-TEC STRING RETICLE TRAY (May 11, 1995)
  • K943802 — HP BACK POINTER SYSTEM (December 7, 1994)
  • K943381 — LASER ALIGNMENT TOOL (August 9, 1994)
  • K941169 — TEC 2101 (MODEL MT-HPLGD) (July 18, 1994)
  • K935760 — TEC 2100 (MODEL MT-LPLGD) (January 25, 1994)

FDA data resources