Anesthesia Apparatus PH-35
FDA 510(k) K830159 · W.E. Leder Enterprises, Inc.
510(k) numberK830159
Submission
- Device name
- Anesthesia Apparatus PH-35
- Applicant
- W.E. Leder Enterprises, Inc.
Mchenry, IL, US - Received
- January 13, 1983
- Decision date
- March 9, 1983
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K831877 | Arf 850 ECBK · Traditional | 11/03/1983SE |
| K831981 | LaryngescopeCCW · Traditional | 09/29/1983SE |
| K831878 | Cardio-Scope Mini MonitorDPS · Traditional | 09/29/1983SE |
| K830161 | Anesthesia Apatatus #D-25BSZ · Traditional | 03/09/1983SE |
| K830160 | Anesthesia Apparatus #Fo 20SBSZ · Traditional | 03/09/1983SE |
Questions and answers
When was Anesthesia Apparatus PH-35 cleared by the FDA?
Anesthesia Apparatus PH-35 (K830159) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 55 days after the submission was received.
What is the product code of K830159?
The FDA product code is BSZ – Gas-Machine, Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.5160.