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510(k) K954037

FIELD TREND by Synemed, Inc. — Product Code HPT

K954037 is an FDA 510(k) premarket notification submitted by Synemed, Inc. for the device "FIELD TREND". The FDA issued a decision of Substantially Equivalent on November 17, 1995. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Synemed, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1995
Date Received
August 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perimeter, Automatic, Ac-Powered
Device Class
Class I
Regulation Number
886.1605
Review Panel
OP
Submission Type

Other clearances by Synemed, Inc.

  • K852936 — THE FIELDMASTER MODEL 275 (October 15, 1985)
  • K833274 — DERMATOLOGY HANDPIECE-OPHTH LASER (December 3, 1983)
  • K831085 — SYNEVAC VACUUM SOURCE UNIT (June 8, 1983)
  • K828585 — OPTHALAS PHOTOCOAGULATOR (January 3, 1983)
  • K822853 — MODEL 200 SQUID (October 18, 1982)
  • K813282 — SYNEVAC VACUUM CURETTAGE SYSTEMS (December 14, 1981)
  • K811270 — SCOPE MASTER (September 8, 1981)

Other clearances for product code HPT

  • K092187 — MAIA, MODEL 1 (May 27, 2010)
  • K093213 — GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES (March 12, 2010)
  • K091579 — FORESEE HOME (December 23, 2009)
  • K063310 — TRUEFIELD ANALYZER (August 2, 2007)
  • K050350 — THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) (April 29, 2005)
  • K023623 — NOVAVISION, MODEL 2.0 (April 22, 2003)
  • K971156 — KASHA VISUAL FIELD SYSTEM (May 28, 1997)
  • K961090 — AUTOMATIC VISUAL FIELD PLOTTER AP-125 (June 17, 1996)
  • K954167 — HUMPHREY FIELD ANALYZER (HFA II) (November 24, 1995)
  • K943234 — MS-30 AUTOMATIC PERIMETER (July 27, 1994)

FDA data resources