Fukuda Denshi Model Spirosift SP-5000
FDA 510(k) K922428 · Fukuda Denshi USA, Inc.
510(k) numberK922428
Submission
- Device name
- Fukuda Denshi Model Spirosift SP-5000
- Applicant
- Fukuda Denshi USA, Inc.
Redmond, WA, US - Received
- May 22, 1992
- Decision date
- January 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K081891 | Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorMHX · Traditional | 08/29/2008SE |
| K050363 | Fukuda Denshi Model UF-850XTDIYN · Special | 02/17/2005SE |
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Questions and answers
When was Fukuda Denshi Model Spirosift SP-5000 cleared by the FDA?
Fukuda Denshi Model Spirosift SP-5000 (K922428) received a 510(k) decision of Substantially Equivalent on January 15, 1993, 238 days after the submission was received.
What is the product code of K922428?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.