Ari Standard Anesthesia Record
FDA 510(k) K854213 · Agilent Technologies, Inc.
510(k) numberK854213
Submission
- Device name
- Ari Standard Anesthesia Record
- Applicant
- Agilent Technologies, Inc.
Pittsburgh, PA, US - Received
- October 17, 1985
- Decision date
- December 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7)BSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/25/2026SE |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)BSZ · Traditional | Drägerwerk AG Co. Kgaa | 05/21/2026SE |
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i…BSZ · Traditional | Codonics.Incorporated | 07/11/2025SE |
| K230931 | AtlanBSZ · Traditional | Drägerwerk AG Co. Kgaa | 07/23/2023SE |
| K213867 | Carestation 750/750cBSZ · Traditional | Datex-Ohmeda, Inc. | 03/28/2023SE |
| K201957 | A8, A9 Anesthesia SystemBSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 03/26/2021SE |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemBSZ · Traditional | Maquet Critical Care AB | 03/18/2020SE |
| K171311 | A5 Anesthesia SystemBSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 01/12/2018SE |
| K171292 | A7 Anesthesia SystemBSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 01/12/2018SE |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…BSZ · Traditional | Datex-Ohmeda, Inc. | 11/03/2017SE |
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| 510(k) | Device | Decision |
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| K163367 | GenetiSure Dx Postnatal AssayPFX · Traditional | 08/11/2017SE |
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| K012094 | Modification to Device Link System, Model M2376AMWI · Special | 07/20/2001SE |
| K011824 | Agilent M2636B Telemon B Monitor (Telemon B)DSI · Special | 07/02/2001SE |
| K010634 | Heartstream XL Defibibrillator/Monitor, Model M4735A, Heartstream XLT…MKJ · Traditional | 06/11/2001SE |
| K011578 | M2376A Devicelink System, Model M2376AMWI · Special | 06/08/2001SE |
| K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870AMKJ · Traditional | 05/02/2001SE |
| K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154MHX · Special | 05/01/2001SE |
| K010453 | M2376A Devicelink SystemMWI · Special | 03/02/2001SE |
| K010342 | M2376A Devicelink System, Model M2376AMWI · Special | 02/14/2001SE |
Questions and answers
When was Ari Standard Anesthesia Record cleared by the FDA?
Ari Standard Anesthesia Record (K854213) received a 510(k) decision of Substantially Equivalent on December 19, 1985, 63 days after the submission was received.
What is the product code of K854213?
The FDA product code is BSZ – Gas-Machine, Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.5160.