Home / 510(k) Clearances / K852936

510(k) K852936

THE FIELDMASTER MODEL 275 by Synemed, Inc. — Product Code HPT

K852936 is an FDA 510(k) premarket notification submitted by Synemed, Inc. for the device "THE FIELDMASTER MODEL 275". The FDA issued a decision of Substantially Equivalent on October 15, 1985. 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
October 15, 1985
Date Received
July 10, 1985
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.

  • K954037 — FIELD TREND (November 17, 1995)
  • 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)
  • K954037 — FIELD TREND (November 17, 1995)

FDA data resources