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510(k) K822853

MODEL 200 SQUID by Synemed, Inc. — Product Code HPT

K822853 is an FDA 510(k) premarket notification submitted by Synemed, Inc. for the device "MODEL 200 SQUID". The FDA issued a decision of Substantially Equivalent on October 18, 1982. 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 18, 1982
Date Received
September 27, 1982
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)
  • 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)
  • 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