510(k) K902300
K902300 is an FDA 510(k) premarket notification submitted by Progressive Productions , Ltd. for the device "EASY BREATHER MODEL 100 ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 19, 1990. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935. Progressive Productions , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1990
- Date Received
- May 23, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, External Body, Negative Pressure, Adult (Cuirass)
- Device Class
- Class II
- Regulation Number
- 868.5935
- Review Panel
- AN
- Submission Type