510(k) K843700
K843700 is an FDA 510(k) premarket notification submitted by Future Impex Corp. for the device "ST-200A W/MAXIMAL VOLUNTARY VENTILLAT-". The FDA issued a decision of Substantially Equivalent on October 24, 1984. Future Impex Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 1984
- Date Received
- September 20, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No