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510(k) K003663

SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE by Spacelabs Medical, Inc. — Product Code BSZ

K003663 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE". The FDA issued a decision of Substantially Equivalent on June 28, 2001. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2001
Date Received
November 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type

Other clearances by Spacelabs Medical, Inc.

  • K120616 — SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 (March 29, 2012)
  • K112962 — SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) (November 2, 2011)
  • K102422 — SPACELABS MEDICAL PATIENT MONITORS (December 7, 2010)
  • K093501 — ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION (November 24, 2009)
  • K082045 — MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (August 1, 2008)
  • K063490 — SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 (March 15, 2007)
  • K062095 — MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (September 29, 2006)
  • K062278 — SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 (September 19, 2006)
  • K060900 — SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES (June 23, 2006)
  • K053599 — SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (April 19, 2006)

Other clearances for product code BSZ

  • K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7) (June 25, 2026)
  • K252746 — Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) (May 21, 2026)
  • K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related (July 11, 2025)
  • K230931 — Atlan (July 23, 2023)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K201957 — A8, A9 Anesthesia System (March 26, 2021)
  • K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (March 18, 2020)
  • K171292 — A7 Anesthesia System (January 12, 2018)
  • K171311 — A5 Anesthesia System (January 12, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)

FDA data resources