510(k) K914459
K914459 is an FDA 510(k) premarket notification submitted by Rocky Mountain Research, Inc. for the device "AUTOMATIC TUBING CLAMP". The FDA issued a decision of Substantially Equivalent on Jun 24, 1992. The device falls under product code FIG (Clamp, Tubing, Blood, Automatic), a Class II device regulated under 21 CFR 876.5820. Rocky Mountain Research, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 24, 1992
- Date Received
- Oct 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Tubing, Blood, Automatic
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type