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510(k) K781801

MAXI-CHAIR by Surgical Mechanical Research, Inc. — Product Code HME

K781801 is an FDA 510(k) premarket notification submitted by Surgical Mechanical Research, Inc. for the device "MAXI-CHAIR". The FDA issued a decision of Substantially Equivalent on November 3, 1978. The device falls under product code HME (Chair, Ophthalmic, Ac-Powered), a Class I device regulated under 21 CFR 886.1140. Surgical Mechanical Research, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1978
Date Received
October 23, 1978
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 Surgical Mechanical Research, Inc.

  • K803195 — SYSTEM 1 INSTRUMENT STAND (February 4, 1981)
  • K800382 — CLEAR-VIEW MIRROR WARMER (May 14, 1980)
  • K800526 — SMR H-CHAIR (March 18, 1980)

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)
  • K864494 — MODEL 6500 OPTHALMIC CHAIR (December 15, 1986)
  • K864574 — MAC 150E OPTHALMIC CHAIR (December 15, 1986)
  • K863728 — THE ERGOSYSTEM CHAIR (October 31, 1986)
  • K863008 — -OM WEST 2000 GNATUS CHAIR (September 24, 1986)
  • K853743 — TECHNA VISION, INC. ELECTRIC CHAIR (October 17, 1985)
  • K853149 — RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (September 5, 1985)

FDA data resources