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510(k) K925258

DYNAMIC PRESSURE MONITOR 2000M AND 2000C by Pin Dot Products, Inc. — Product Code JFC

K925258 is an FDA 510(k) premarket notification submitted by Pin Dot Products, Inc. for the device "DYNAMIC PRESSURE MONITOR 2000M AND 2000C". The FDA issued a decision of Substantially Equivalent on March 9, 1993. The device falls under product code JFC (System, Pressure Measurement, Intermittent), a Class I device regulated under 21 CFR 890.1600. Pin Dot Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1993
Date Received
October 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Pressure Measurement, Intermittent
Device Class
Class I
Regulation Number
890.1600
Review Panel
PM
Submission Type

Other clearances by Pin Dot Products, Inc.

  • K913510 — MECHANICAL SHAPE SENSOR (September 23, 1991)
  • K913553 — PIN DOT GROWTH/DIAL LINKS (September 5, 1991)
  • K913548 — PIN DOT ALUMINUM PAN (September 5, 1991)
  • K913549 — PIN DOT MOUNTING BRACKETS (September 5, 1991)
  • K913511 — IMPALA AXLES (September 5, 1991)
  • K913509 — IMPALA WHEELS (September 5, 1991)
  • K913546 — IMPALA CASTERS (September 5, 1991)
  • K913550 — PIN DOT TRUNION MOUNTS (September 5, 1991)
  • K913507 — ARMREST (September 5, 1991)
  • K913545 — PIN DOT FLIP-DOWN ABDUCTOR (September 5, 1991)

Other clearances for product code JFC

  • K924705 — FORCE SENSING ARRAY (May 12, 1993)
  • K925052 — QA PRESSURE MEASUREMENT SYSTEM (March 9, 1993)
  • K915278 — CDG GAIT ANALYSES SYSTEM (April 7, 1992)
  • K914776 — OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR (December 19, 1991)
  • K913510 — MECHANICAL SHAPE SENSOR (September 23, 1991)
  • K881284 — COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE (July 21, 1988)
  • K882139 — 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME (June 22, 1988)
  • K861260 — PEDABAROGRAPH (May 2, 1986)
  • K831800 — TEXAS INTERFACE PRESSURE EVALUATOR-TIPE (August 16, 1983)
  • K823681 — MODEL ICPM & ACCESSORIES (February 23, 1983)

FDA data resources