Home / 510(k) Clearances / K851971

510(k) K851971

SERIES 7000/HOLTER RECORDER by Pfizer, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1985
Date Received
May 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Pfizer, Inc.

  • K181102 — ThermaCare Quick Therapy TENS (September 15, 2018)
  • K991620 — VISINE FOR CONTACTS (September 24, 1999)
  • K892264 — ORALCHEK SUPER-SOFT BRUSH (June 14, 1989)
  • K892360 — WATER JEL STERILE GEL-SOAKED BURN DRESSING (June 5, 1989)
  • K881378 — PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (June 17, 1988)
  • K854726 — MEDI-WIPES UNITED ANTISEPTIC SKIN PREP (February 24, 1986)
  • K850413 — MEC HIP BOLT (July 15, 1985)
  • K850443 — MEC ROD CONNECTOR (July 15, 1985)
  • K850840 — HOWMEDICA THREADED ACETABULAR COMPONENT (July 15, 1985)
  • K850403 — MEC DISTAL FEMORAL BOLT (July 15, 1985)

Other clearances for product code DSH

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K243603 — AeviceMD (May 5, 2025)
  • K242583 — AT-Patch (ATP-C130/ATP-C70) (May 2, 2025)
  • K232670 — HiCardi+ H100 (September 20, 2024)
  • K233906 — S-Patch (S-Patch ExL) (February 16, 2024)
  • K231104 — ABPMpro (November 27, 2023)
  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)
  • K230184 — Holter ECG and ABP System (September 25, 2023)
  • K231289 — S-Patch Ex Wearable ECG Patch (August 30, 2023)