Model 9100 PFT/DICO
FDA 510(k) K221030 · Vitalograph Ireland, Ltd.
510(k) numberK221030
Submission
- Device name
- Model 9100 PFT/DICO
- Applicant
- Vitalograph Ireland, Ltd.
Ennis Co Clare, IE - Received
- April 7, 2022
- Decision date
- July 15, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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Questions and answers
When was Model 9100 PFT/DICO cleared by the FDA?
Model 9100 PFT/DICO (K221030) received a 510(k) decision of Substantially Equivalent on July 15, 2022, 99 days after the submission was received.
What is the product code of K221030?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.