510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K981530Substantially Equivalent

Spacelabs Medical 90519 Anesthesia Delivery System

GE Healthcare, Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981530 is the FDA 510(k) clearance record for SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM, a class II device, cleared for Spacelabs Medical, Inc. on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K981530.

Clearance record

Decision date
Received
(205 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
Spacelabs Medical, Inc. P.O. Box 97013, Redmond WA
510(k) summary
Summary
Third party review
No

Clearances, product code BSZ

Trailing 12 months
2 clearances under product code BSZ in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BSZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260