510(k) K891927
K891927 is an FDA 510(k) premarket notification submitted by Lucas & Rhea Mfg. for the device "TELEMETRY POWER PACK MODEL 2". The FDA issued a decision of Substantially Equivalent on April 26, 1990. The device falls under product code FCP (Box, Battery, Pocket), a Class I device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 1990
- Date Received
- March 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Box, Battery, Pocket
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type