510(k) K831033
K831033 is an FDA 510(k) premarket notification submitted by Lancer Assoc. for the device "GIREX". The FDA issued a decision of Substantially Equivalent on April 27, 1983. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370. Lancer Assoc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 1983
- Date Received
- March 31, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Non-Measuring
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type