510(k) K981841
K981841 is an FDA 510(k) premarket notification submitted by Respiraid , Ltd. for the device "BREATHE EASY, MODELS AD AND CD". The FDA issued a decision of Substantially Equivalent on October 13, 1998. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1998
- Date Received
- May 26, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Air, Medical Recirculating
- Device Class
- Class II
- Regulation Number
- 880.5045
- Review Panel
- HO
- Submission Type