510(k) K842369
K842369 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "ELECATH INFANT ARTERIAL & VENOUS CANNU". The FDA issued a decision of Substantially Equivalent on August 27, 1984. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Electro-Catheter Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1984
- Date Received
- June 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Therapeutic (Incentive)
- Device Class
- Class II
- Regulation Number
- 868.5690
- Review Panel
- AN
- Submission Type