510(k) K842580
K842580 is an FDA 510(k) premarket notification submitted by Infrasonics Corp. for the device "ACCESSORY FOR ADULT VOL. VENTILATOR". The FDA issued a decision of Substantially Equivalent on August 24, 1984. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Infrasonics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1984
- Date Received
- July 3, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Bacterial, Breathing-Circuit
- Device Class
- Class II
- Regulation Number
- 868.5260
- Review Panel
- HO
- Submission Type