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510(k) K910223

CPI MODEL 2215/SEAMED MODEL 3400 by Seamed Corp. — Product Code DTC

K910223 is an FDA 510(k) premarket notification submitted by Seamed Corp. for the device "CPI MODEL 2215/SEAMED MODEL 3400". The FDA issued a decision of Substantially Equivalent on March 19, 1991. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Seamed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1991
Date Received
January 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function
Device Class
Class II
Regulation Number
870.3630
Review Panel
CV
Submission Type

Other clearances by Seamed Corp.

  • K923398 — CPI MODEL 2215 (August 14, 1992)
  • K915364 — CHRONOCOR VI MODEL 5012 (February 7, 1992)
  • K912507 — CPI MODEL 2215 & SEAMED MODEL 3400 (September 3, 1991)
  • K883930 — SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY (November 9, 1988)
  • K872551 — SEAMED MODEL 3200 (July 31, 1987)
  • K863903 — SEA MED MODEL 6000 (December 10, 1986)
  • K860462 — SEAMED MODEL 3000 (August 19, 1986)
  • K854648 — SEAMED MODEL 4000 (January 16, 1986)
  • K852746 — EXTERNAL PACEMAKER TELECTRONICS TE200 (September 12, 1985)
  • K851900 — SEA MED DDD PACING SYSTEM ANALYZER (July 19, 1985)

Other clearances for product code DTC

  • K170815 — PSA Cable (July 6, 2017)
  • K083674 — PK-141 PATIENT CABLE (April 1, 2009)
  • K011729 — SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 (August 30, 2001)
  • K002497 — MODEL 4810 ANALYZER OUTPUT ADAPTER (October 10, 2000)
  • K961582 — EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (November 8, 1996)
  • K903966 — EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 (June 19, 1991)
  • K910595 — MODEL 5311B A-V PACING SYSTEM ANALYZER (May 7, 1991)
  • K901332 — PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE (May 9, 1990)
  • K896632 — MEDTRONIC MODEL 5401B TEST CABLE (December 13, 1989)
  • K884331 — MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER (January 10, 1989)

FDA data resources