Sleep I/T-5 and Sleep I/T-8
FDA 510(k) K904432 · Cns, Inc.
510(k) numberK904432
Submission
- Device name
- Sleep I/T-5 and Sleep I/T-8
- Applicant
- Cns, Inc.
Chanhassen, MN, US - Received
- September 28, 1990
- Decision date
- July 10, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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|---|---|---|
| K955711 | Breathe Right Nasal StripLWF · Traditional | 05/30/1996SE |
| K954914 | Breathe Right Nasal StripLWF · Traditional | 02/27/1996SE |
| K953772 | Breathe Right Nasal StripLWF · Traditional | 10/20/1995SE |
| K950273 | Sleep Test(Tm)MNR · Traditional | 09/19/1995SE |
| K921220 | Breathe RightLWF · Traditional | 10/07/1993SE |
| K912436 | Am-PakGWL · Traditional | 10/18/1991SE |
| K910452 | Respi-Pak Rt-PakBZG · Traditional | 04/16/1991SE |
| K901549 | CNS Satellite 100, 200, 1000, 2000 Electroence.GWQ · Traditional | 10/24/1990SE |
| K897107 | Poly G Physiological Data RecorderBXO · Traditional | 03/12/1990SE |
| K860829 | CNS 4/8 and CT 48.1 SoftwareGWS · Traditional | 05/29/1986SE |
Questions and answers
When was Sleep I/T-5 and Sleep I/T-8 cleared by the FDA?
Sleep I/T-5 and Sleep I/T-8 (K904432) received a 510(k) decision of Substantially Equivalent on July 10, 1991, 285 days after the submission was received.
What is the product code of K904432?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.