Model 509M Pulse Oximeter, Model 509M
FDA 510(k) K032755 · Respironics Novametrix, Inc.
510(k) numberK032755
Submission
- Device name
- Model 509M Pulse Oximeter, Model 509M
- Applicant
- Respironics Novametrix, Inc.
Wallingford, CT, US - Received
- September 5, 2003
- Decision date
- May 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 05/11/2026SE |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional | Philips Medizin Systeme | 05/01/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | Unimed Medical Supplies, Inc. | 04/14/2026SE |
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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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| K080652 | Mercury VCO2 Module with Capnostat 5BZK · Special | 06/20/2008SE |
| K053174 | Loflo C5 CO2 SensorCCK · Special | 01/12/2006SE |
| K042601 | Capnostat 5CCK · Special | 11/19/2004SE |
| K032971 | Tidal Wave SP Model 710/715 and 715DQA · Traditional | 08/26/2004SE |
| K032949 | Spot Check Pulse OXIMETER,512/513DQA · Traditional | 08/23/2004SE |
| K041450 | Modification to Nico with Mars, Model 7300CCK · Special | 06/18/2004SE |
| K030886 | Nico with Mars, Model 7300CCK · Traditional | 10/07/2003SE |
Questions and answers
When was Model 509M Pulse Oximeter, Model 509M cleared by the FDA?
Model 509M Pulse Oximeter, Model 509M (K032755) received a 510(k) decision of Substantially Equivalent on May 21, 2004, 259 days after the submission was received.
What is the product code of K032755?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.