510(k) K921569
K921569 is an FDA 510(k) premarket notification submitted by Mnlase, Inc. for the device "ORS-200". The FDA issued a decision of Substantially Equivalent on June 9, 1992. The device falls under product code JRM (Freezer), a Class I device regulated under 21 CFR 862.2050. Mnlase, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1992
- Date Received
- April 2, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Freezer
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type