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510(k) K870856

COSMOS by Pausch Corp. — Product Code IYB

K870856 is an FDA 510(k) premarket notification submitted by Pausch Corp. for the device "COSMOS". The FDA issued a decision of Substantially Equivalent on March 30, 1987. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Pausch Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1987
Date Received
March 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Mount, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1770
Review Panel
RA
Submission Type

Other clearances by Pausch Corp.

  • K081073 — HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F (December 5, 2008)
  • K973864 — COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO (June 17, 1998)
  • K973834 — CS2000 & CS2000 TOMO (April 30, 1998)
  • K903395 — UROMAT 2000 (August 30, 1990)
  • K790741 — COMPACT SYSTEM (April 26, 1979)
  • K790742 — KS-78 VERTICAL WALL CASSETTE HOLDER (April 26, 1979)
  • K790740 — BS 66, UNIVERSAL BUCKY STAND (April 26, 1979)
  • K790743 — COORDINATUS, HORIZONTAL RADIOGRAPHOC (April 23, 1979)

Other clearances for product code IYB

  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 1995)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K940442 — MPR-814 (June 9, 1994)
  • K935004 — MODEL ALPHA TS-2 (December 13, 1993)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)
  • K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 17, 1992)
  • K925170 — SHIMADZU X-RAY TUBE STAND BH-100 SERIES (December 7, 1992)
  • K920727 — CEILING TUBE SUPPORT CH-30X (April 16, 1992)

FDA data resources