Sleep Test(Tm)
FDA 510(k) K950273 · Cns, Inc.
510(k) numberK950273
Submission
- Device name
- Sleep Test(Tm)
- Applicant
- Cns, Inc.
Chanhassen, MN, US - Received
- January 23, 1995
- Decision date
- September 19, 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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| K921220 | Breathe RightLWF · Traditional | 10/07/1993SE |
| K912436 | Am-PakGWL · Traditional | 10/18/1991SE |
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| K901549 | CNS Satellite 100, 200, 1000, 2000 Electroence.GWQ · Traditional | 10/24/1990SE |
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Questions and answers
When was Sleep Test(Tm) cleared by the FDA?
Sleep Test(Tm) (K950273) received a 510(k) decision of Substantially Equivalent on September 19, 1995, 239 days after the submission was received.
What is the product code of K950273?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.