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Spacelabs Series 1000

by Spacelabs, Inc.

510(k) K760612

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760612 Date21 Sep 1976ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Spacelabs Series 1000 is a cardiovascular device as defined by its device type and advisory committee classification. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.

The device was manufactured by Spacelabs, Inc. and received FDA 510(k) authorization under k-number K760612 on September 21, 1976. It is identified by product code DPS and was submitted from the address in McHenry, Illinois, United States.

Other devices from Spacelabs, Inc.

See all devices from Spacelabs, Inc. →

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Spacelabs Series 1000 used for?

    The Spacelabs Series 1000 is classified as a cardiovascular device based on its device type and advisory committee classification, indicating its intended use relates to cardiovascular function or monitoring as defined by regulatory submission.

  • How was the Spacelabs Series 1000 authorized for market?

    The device received FDA 510(k) clearance through a traditional submission process, determined to be substantially equivalent to a predicate device, with authorization granted under k-number K760612 on September 21, 1976.

  • Who manufactured the Spacelabs Series 1000 and where was it submitted from?

    The Spacelabs Series 1000 was manufactured by Spacelabs, Inc. and submitted from their address at 803 N. Front St. Suite 3, McHenry, Illinois, United States, as recorded in the FDA 510(k) database.