Pulse oximeter NBM-200
FDA 510(k) K142209 · Orsense, Ltd.
510(k) numberK142209
Submission
- Device name
- Pulse oximeter NBM-200
- Applicant
- Orsense, Ltd.
Petah-Tikva, IL - Received
- August 11, 2014
- Decision date
- January 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
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| K251751 | Spo2 Sensor CSS032DDQA · Traditional | Shenzhen Ykd Technology Co., Ltd. | 12/19/2025SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
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Questions and answers
When was Pulse oximeter NBM-200 cleared by the FDA?
Pulse oximeter NBM-200 (K142209) received a 510(k) decision of Substantially Equivalent on January 16, 2015, 158 days after the submission was received.
What is the product code of K142209?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.