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FDA Import Refusal K65-0038782-9/4/5 — Spacelabs Healthcare, Inc.

Spacelabs Healthcare, Inc. — FEI 3010157426

The FDA refused shipment K65-0038782-9/4/5 from Spacelabs Healthcare, Inc. (United States) on August 7, 2002. The refused product falls under Devices — SYSTEM, ECG ANALYSIS,. Cited charges: 118,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 7, 2002
Country
United States
Product Category
Devices
Product Code
74LOS SYSTEM, ECG ANALYSIS,
Charges
118,341

Recent inspections

  • 1179915 (NAI Thu Sep 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056344 (NAI Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003822 (VAI Thu Mar 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942482 (VAI Fri Jul 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872781 (OAI Wed Apr 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • SCS-9180651-7/41/1 (Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9180651-7/51/1 (Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9180651-7/61/1 (Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9193527-4/41/1 (Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9193527-4/51/1 (Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources