A9800 Anesthesia Workstation

FDA 510(k) K131790 · Oricare, Inc.

Substantially Equivalent

510(k) numberK131790

Submission

Device name
A9800 Anesthesia Workstation
Applicant
Oricare, Inc.
Quakertow., PA, US
Received
June 18, 2013
Decision date
May 9, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BSZ – Gas-Machine, Anesthesia
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5160
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BSZ

510(k)DeviceApplicantDecision
K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)BSZ · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.06/25/2026SE
K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)BSZ · Traditional Drägerwerk AG Co. Kgaa05/21/2026SE
K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i…BSZ · Traditional Codonics.Incorporated07/11/2025SE
K230931AtlanBSZ · Traditional Drägerwerk AG Co. Kgaa07/23/2023SE
K213867Carestation 750/750cBSZ · Traditional Datex-Ohmeda, Inc.03/28/2023SE
K201957A8, A9 Anesthesia SystemBSZ · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.03/26/2021SE
K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemBSZ · Traditional Maquet Critical Care AB03/18/2020SE
K171311A5 Anesthesia SystemBSZ · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.01/12/2018SE
K171292A7 Anesthesia SystemBSZ · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.01/12/2018SE
K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…BSZ · Traditional Datex-Ohmeda, Inc.11/03/2017SE

More from Datex-Ohmeda, Inc.

510(k)DeviceDecision
K120931Critical Care VentilatorCBK · Traditional 06/06/2013SE
K122875Oricare L2700FSY · Traditional 12/18/2012SE
K113338Medical Air CompressorBTI · Traditional 08/10/2012SE

Questions and answers

When was A9800 Anesthesia Workstation cleared by the FDA?

A9800 Anesthesia Workstation (K131790) received a 510(k) decision of Substantially Equivalent on May 9, 2014, 325 days after the submission was received.

What is the product code of K131790?

The FDA product code is BSZ – Gas-Machine, Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.5160.