510(k) K893213
K893213 is an FDA 510(k) premarket notification submitted by Progressive Productions , Ltd. for the device "EASY BREATHER MODEL 100". The FDA issued a decision of Substantially Equivalent on August 4, 1989. 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
- August 4, 1989
- Date Received
- April 27, 1989
- 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