510(k) K840313
K840313 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code BWB (Forceps, Tube Introduction), a Class I device regulated under 21 CFR 868.5780. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1984
- Date Received
- January 24, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Tube Introduction
- Device Class
- Class I
- Regulation Number
- 868.5780
- Review Panel
- AN
- Submission Type