Nico with Mars, Model 7300
FDA 510(k) K030886 · Respironics Novametrix, Inc.
510(k) numberK030886
Submission
- Device name
- Nico with Mars, Model 7300
- Applicant
- Respironics Novametrix, Inc.
Wallingford, CT, US - Received
- March 21, 2003
- Decision date
- October 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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More from Southmedic, Inc.
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| K091459 | Philips NM3 Monitor, Model 7900BZK · Special | 07/28/2009SE |
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| 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 |
| K032755 | Model 509M Pulse Oximeter, Model 509MDQA · Traditional | 05/21/2004SE |
Questions and answers
When was Nico with Mars, Model 7300 cleared by the FDA?
Nico with Mars, Model 7300 (K030886) received a 510(k) decision of Substantially Equivalent on October 7, 2003, 200 days after the submission was received.
What is the product code of K030886?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.