510(k) K151570
- Device
- Carestation 620/650/650C
- Applicant
- DATEX-OHMEDA, INC.
- 510(k) number
- K151570
- Product code
- BSZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-01-21
- Date received
- 2015-06-10
- Regulation
- 868.5160
- Classification name
- Gas-machine, Anesthesia
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES RASKOB
- Address
- 3030 Ohmeda Dr. P.O.Box 7550 Madison WI US 53707 53707
FDA Registration Numbers#
- 9710602
- 3001104093
- 3007603826
- 9611500
- 1054713
- 2020813
- 1000122786
- 3009156722
- 3013188547
- 8010042
- 2518157
- 3005803793
- 3010703925
- 8043316
- 3010157426
- 3007238566
- 3022543477
- 3016618143
- 9610531
- 1066270
- 3021559257
- 9617604
- 3035111606
- 2112667
- 3009129579
- 3005783425
- 9611295
- 1530958
- 3000126629
- 3003589956
- 2221819
- 1066427
Source Documents#
Other 510(k) Records For Product Code BSZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | 2026-05-21 |
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) | Codonics.Incorporated | 2025-07-11 |
| K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023-07-23 |
| K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | 2023-03-28 |
| K201957 | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-26 |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | 2020-03-18 |
| K171311 | A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 |
| K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | Datex-Ohmeda, Inc. | 2017-11-03 |
| K170872 | Aisys CS2 | Datex-Ohmeda, Inc. | 2017-08-15 |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | Maquet Critical Care AB | 2017-03-29 |
| K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-27 |
| K143530 | Aespire View | Datex-Ohmeda, Inc. | 2015-04-24 |
| K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-01-23 |
| K140264 | MADM | Thornhill Research, Inc. | 2015-01-05 |
Legacy Summary#
summary
FDA Review#
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