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510(k) K843046

RELIANCE TREATMENT CABINET by F. & F. Koenigkramer — Product Code ETF

K843046 is an FDA 510(k) premarket notification submitted by F. & F. Koenigkramer for the device "RELIANCE TREATMENT CABINET". The FDA issued a decision of Substantially Equivalent on September 27, 1984. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. F. & F. Koenigkramer has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1984
Date Received
August 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
Review Panel
EN
Submission Type

Other clearances by F. & F. Koenigkramer

  • K860519 — RELIANCE MODEL 200 PODIATRY CHAIR (February 19, 1986)
  • K853150 — RELIANCE 6100 (September 5, 1985)
  • K853149 — RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (September 5, 1985)
  • K853151 — RELIANCE 5000 (September 5, 1985)
  • K834060 — RELIANCE OPHTHALMIC SLIT LAMP R-083 (February 4, 1984)
  • K831568 — RELIANCE TEMPO OPHTH. INSTR STAND (June 30, 1983)
  • K812544 — RELIANCE OPHTHALMIC INSTRUMENT CONTROL (September 21, 1981)
  • K761147 — RELIANCE MOD-U-LINE M-700 (January 28, 1977)

Other clearances for product code ETF

  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K945395 — PREMIER MIRROR WARMER (January 18, 1995)
  • K932470 — LANGGASSE 90 (August 25, 1993)
  • K911901 — MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE (July 26, 1991)
  • K910781 — #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES (May 15, 1991)
  • K910243 — MOBILE TREATMENT CART (April 17, 1991)
  • K896298 — JEDMED S CHAIR (January 26, 1990)
  • K896273 — SYSTEMA ENT CABINET (January 26, 1990)
  • K881958 — JEDMED MAXIM ENT CABINET (July 15, 1988)
  • K860940 — MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (May 2, 1986)

FDA data resources