Modification EZ-1 System Repiratory Sensors
FDA 510(k) K013905 · Pro-Tech Services, Inc.
510(k) numberK013905
Submission
- Device name
- Modification EZ-1 System Repiratory Sensors
- Applicant
- Pro-Tech Services, Inc.
Mukilteo, WA, US - Received
- November 26, 2001
- Decision date
- April 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MNR – Ventilatory Effort Recorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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Questions and answers
When was Modification EZ-1 System Repiratory Sensors cleared by the FDA?
Modification EZ-1 System Repiratory Sensors (K013905) received a 510(k) decision of Substantially Equivalent on April 22, 2002, 147 days after the submission was received.
What is the product code of K013905?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.