Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62
FDA 510(k) K082478 · Welch Allyn, Inc.
510(k) numberK082478
Submission
- Device name
- Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- August 28, 2008
- Decision date
- March 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
| K222443 | Air Smart Extra SpirometerBZG · Traditional | Feellife Health, Inc. | 08/09/2023SE |
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| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
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| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemNFJ · Traditional | 07/16/2018SE |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…MHX · Special | 06/30/2017SE |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI · Traditional | 12/19/2014SE |
| K141582 | CP150 Electrocardiograph with Spirometry OptionDPS · Special | 07/11/2014SE |
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Questions and answers
When was Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62 cleared by the FDA?
Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62 (K082478) received a 510(k) decision of Substantially Equivalent on March 9, 2009, 193 days after the submission was received.
What is the product code of K082478?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.