AM-6000 Anesthesia Machine
FDA 510(k) K120075 · Advanced Instrumentations, Inc.
510(k) numberK120075
Submission
- Device name
- AM-6000 Anesthesia Machine
- Applicant
- Advanced Instrumentations, Inc.
Hialeah, FL, US - Received
- January 10, 2012
- Decision date
- January 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
More from Datex-Ohmeda, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemIYO · Abbreviated | 12/01/2017SE |
| K172055 | DUS-7000 Digital Color Doppler Ultrasound SystemIYN · Abbreviated | 08/31/2017SE |
| K141194 | FM-3000 Fetal MonitorHGM · Traditional | 11/19/2014SE |
| K132077 | Patient MonitorMHX · Traditional | 04/23/2014SE |
| K132059 | Diagnostic Ultrasound SystemIYN · Traditional | 10/25/2013SE |
| K123048 | Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProMHX · Traditional | 01/11/2013SE |
| K112317 | FM-9000 Plus Fetal and Maternal MonitorHGM · Traditional | 12/21/2011SE |
| K112529 | TD-5000 & TD-6000 Ultrasonic Tabletop DopplerKNG · Traditional | 10/27/2011SE |
| K112022 | DUS-3000/DUS-3000PLUS Digital Ultrasonic Diagnostic Imaging SystemIYO · Traditional | 09/22/2011SE |
| K111934 | PD-100 Series Ultrasonic Pocket DopplerKNG · Traditional | 09/22/2011SE |
Questions and answers
When was AM-6000 Anesthesia Machine cleared by the FDA?
AM-6000 Anesthesia Machine (K120075) received a 510(k) decision of Substantially Equivalent on January 26, 2012, 16 days after the submission was received.
What is the product code of K120075?
The FDA product code is BSZ – Gas-Machine, Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.5160.