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510(k) K872661

RGB CAMERA SYSTEM by Aspen Laboratories, Inc. — Product Code FWF

K872661 is an FDA 510(k) premarket notification submitted by Aspen Laboratories, Inc. for the device "RGB CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 1987. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Aspen Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1987
Date Received
July 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Television, Endoscopic, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

Other clearances by Aspen Laboratories, Inc.

  • K981220 — SYSTEM 7500 ABC ELECTROSURGICAL UNIT (April 21, 1998)
  • K963088 — SHEATH, ELECTROSURGICAL PENCIL (September 13, 1996)
  • K955834 — SYSTEM 6500 ABC ELECTROSURGICAL UNIT (July 11, 1996)
  • K960296 — 4000 ETM (February 20, 1996)
  • K953081 — BEAMER PLUS (October 30, 1995)
  • K953007 — EXCALIBUR PLUS ELECTROSURGICAL UNIT (August 21, 1995)
  • K946104 — SMOKIEVAC ELECTROSURGICAL PENCIL (April 3, 1995)
  • K944012 — ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR (December 21, 1994)
  • K924960 — EXCALIBUR ELECTROSURGICAL UNIT (April 16, 1993)
  • K913213 — SINGLE USE LEE ELECTRODE (February 13, 1992)

Other clearances for product code FWF

  • K053412 — FLEXISCOPE, MODELS 50MH AND 50 MHC (February 23, 2006)
  • K990154 — KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM (June 1, 1999)
  • K982754 — EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N ( (January 8, 1999)
  • K982965 — ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES (November 23, 1998)
  • K982397 — VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM (September 10, 1998)
  • K982409 — VES 1501-M (August 21, 1998)
  • K981819 — ANGIOLAZ VES-1CAM (August 4, 1998)
  • K944707 — ISOLATED CAMERA HEAD (October 7, 1994)
  • K930297 — FUJINON VIDEO LAPAROSCOPE, MODIFIED (March 29, 1994)
  • K934682 — SURGICAL VIDEO CAMERA AND ACCESSORIES (February 15, 1994)

FDA data resources