Snoring Microphone, SM1
FDA 510(k) K940015 · Pro-Tech, Inc.
510(k) numberK940015
Submission
- Device name
- Snoring Microphone, SM1
- Applicant
- Pro-Tech, Inc.
Woodinville, WA, US - Received
- January 4, 1994
- Decision date
- January 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K913396 | Cannula Style ThermocouplesBZG · Traditional | 05/22/1992SE |
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Questions and answers
When was Snoring Microphone, SM1 cleared by the FDA?
Snoring Microphone, SM1 (K940015) received a 510(k) decision of Substantially Equivalent on January 11, 1995, 372 days after the submission was received.
What is the product code of K940015?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.