510(k) K933041
K933041 is an FDA 510(k) premarket notification submitted by Electone, Inc. for the device "COLD CD ASP MODULE, ITE". The FDA issued a decision of Substantially Equivalent on August 2, 1993. The device falls under product code LRS (I.V. Start Kit), a Class II device regulated under 21 CFR 880.5200. Electone, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1993
- Date Received
- April 28, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- I.V. Start Kit
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- SU
- Submission Type
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.