Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 STD
FDA 510(k) K093308 · Nidek Medical Products, Inc.
510(k) numberK093308
Submission
- Device name
- Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 STD
- Applicant
- Nidek Medical Products, Inc.
Birmingham, AL, US - Received
- October 22, 2009
- Decision date
- January 14, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
Other 510(k)s with product code CAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAW · Traditional | BMC Medical Co., Ltd. | 08/14/2026SE |
| K252399 | Portable Oxygen ConcentratorCAW · Traditional | Honsun (Nantong) Co., Ltd. | 06/17/2026SE |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C)CAW · Traditional | Oxytek Medical Technology Co., Ltd. | 05/29/2026SE |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000)CAW · Traditional | Mv Life, LLC | 04/23/2026SE |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | Devilbiss Healthcare, LLC | 03/26/2026SE |
| K251534 | Oxygen Concentrator (J10A)CAW · Traditional | Foshan Kycare Medical Equipment Co., Ltd. | 12/29/2025SE |
| K252616 | Portable oxygen concentrator (JLO-190P)CAW · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 12/22/2025SE |
| K251764 | Oxygen Concentrator-P2-O5ECAW · Traditional | Qingdao Kingon Medical Science and Technology… | 12/22/2025SE |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional | Shenzhen Harveymed Technology Co., Ltd. | 12/16/2025SE |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
More from Devilbiss Healthcare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K192693 | Nuvo Nano Portable Oxygen ConcentratorCAW · Traditional | 05/07/2020SE |
| K123738 | Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDCAW · Special | 02/28/2013SE |
| K082566 | Mark 5 Nuvo Lite Ocsi and STDCAW · Abbreviated | 12/03/2008SE |
| K040892 | Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905CAW · Special | 04/29/2004SE |
| K032509 | Mark 5 Nuvo (M5C5)CAW · Traditional | 03/18/2004SE |
| K020797 | Pulmo-Mist Compressor Model # 4323BTI · Traditional | 05/03/2002SE |
| K980551 | Silenzio Delta Continuous Positive Airway Pressure SystemBZD · Traditional | 11/17/1998SE |
| K962492 | Silenzio Plus Continuous Positive Airway Pressure SystemBYE · Traditional | 01/23/1997SE |
| K952966 | CP-90 Continuous Positive Airway Pressure SystemBZD · Traditional | 05/07/1996SE |
| K942593 | Oxychek Oxygen AnalyzerCCL · Traditional | 05/03/1995SE |
Questions and answers
When was Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 STD cleared by the FDA?
Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 STD (K093308) received a 510(k) decision of Substantially Equivalent on January 14, 2010, 84 days after the submission was received.
What is the product code of K093308?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.