Home / 510(k) Clearances / K863008

510(k) K863008

-OM WEST 2000 GNATUS CHAIR by Sds Dental, Inc. — Product Code HME

K863008 is an FDA 510(k) premarket notification submitted by Sds Dental, Inc. for the device "-OM WEST 2000 GNATUS CHAIR". The FDA issued a decision of Substantially Equivalent on September 24, 1986. The device falls under product code HME (Chair, Ophthalmic, Ac-Powered), a Class I device regulated under 21 CFR 886.1140. Sds Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1986
Date Received
August 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Ophthalmic, Ac-Powered
Device Class
Class I
Regulation Number
886.1140
Review Panel
OP
Submission Type

Other clearances by Sds Dental, Inc.

  • K990546 — DELSONIC 2000 (November 5, 1999)
  • K990545 — JETSONIC 2000 (August 11, 1999)
  • K964619 — DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) (January 22, 1997)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K902864 — SURGICAL LIGHTING-CENTRA 450 (September 10, 1990)
  • K863011 — DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II (October 10, 1986)
  • K863015 — ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT (October 1, 1986)
  • K863012 — MINILAX SET (October 1, 1986)
  • K863016 — DENTATUS L SET (October 1, 1986)
  • K863013 — ISOLAX PEDAL SET (October 1, 1986)

Other clearances for product code HME

  • K930449 — MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR (July 6, 1993)
  • K914416 — BREATH-EASY, MODIFICATION (June 23, 1992)
  • K894018 — RELIANCE(R) 6200 EXAMINATION CHAIR (September 12, 1989)
  • K870112 — STORZ ENT/OPHTHALMIC MAXI CHAIR (February 12, 1987)
  • K864574 — MAC 150E OPTHALMIC CHAIR (December 15, 1986)
  • K864494 — MODEL 6500 OPTHALMIC CHAIR (December 15, 1986)
  • K863728 — THE ERGOSYSTEM CHAIR (October 31, 1986)
  • K853743 — TECHNA VISION, INC. ELECTRIC CHAIR (October 17, 1985)
  • K853150 — RELIANCE 6100 (September 5, 1985)
  • K853149 — RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (September 5, 1985)

FDA data resources