Pall Pulmonary Function Filter
FDA 510(k) K854062 · Pall Biomedical Products Co.
510(k) numberK854062
Submission
- Device name
- Pall Pulmonary Function Filter
- Applicant
- Pall Biomedical Products Co.
Glen Cove, NY, US - Received
- October 4, 1985
- Decision date
- November 7, 1985
- 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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| K873667 | Pall Leukocyte Removal Filter, PlateletsCAK · Traditional | 01/06/1988SE |
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Questions and answers
When was Pall Pulmonary Function Filter cleared by the FDA?
Pall Pulmonary Function Filter (K854062) received a 510(k) decision of Substantially Equivalent on November 7, 1985, 34 days after the submission was received.
What is the product code of K854062?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.