510(k) K944819
K944819 is an FDA 510(k) premarket notification submitted by Physicians Consulting, Inc. for the device "KRDL 2000". The FDA issued a decision of Substantially Equivalent on March 10, 1995. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Physicians Consulting, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1995
- Date Received
- September 29, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Powered
- Device Class
- Class I
- Regulation Number
- 890.5380
- Review Panel
- PM
- Submission Type