Respi-Pak Rt-Pak
FDA 510(k) K910452 · Cns, Inc.
510(k) numberK910452
Submission
- Device name
- Respi-Pak Rt-Pak
- Applicant
- Cns, Inc.
Eden Prairie, MN, US - Received
- February 1, 1991
- Decision date
- April 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
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| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
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| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
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| K955711 | Breathe Right Nasal StripLWF · Traditional | 05/30/1996SE |
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| 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 |
| K904432 | Sleep I/T-5 and Sleep I/T-8BZQ · Traditional | 07/10/1991SE |
| 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 Respi-Pak Rt-Pak cleared by the FDA?
Respi-Pak Rt-Pak (K910452) received a 510(k) decision of Substantially Equivalent on April 16, 1991, 74 days after the submission was received.
What is the product code of K910452?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.