510(k) K894906
K894906 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER". The FDA issued a decision of Substantially Equivalent on September 18, 1989. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Med-Tek Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1989
- Date Received
- August 1, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Reservoir
- Device Class
- Class I
- Regulation Number
- 868.5320
- Review Panel
- AN
- Submission Type