Filter, Particulate Arresting
FDA 510(k) K760481 · Miles Laboratories, Inc.
510(k) numberK760481
Submission
- Device name
- Filter, Particulate Arresting
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- August 17, 1976
- Decision date
- September 15, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRF – Cleaner, Air, Medical Recirculating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5045
- Specialty
- General Hospital
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Questions and answers
When was Filter, Particulate Arresting cleared by the FDA?
Filter, Particulate Arresting (K760481) received a 510(k) decision of Substantially Equivalent on September 15, 1976, 29 days after the submission was received.
What is the product code of K760481?
The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.