510(k) K851277
K851277 is an FDA 510(k) premarket notification submitted by Medical Equipment Designs, Inc. for the device "MICROSPIRO-SDS". The FDA issued a decision of Substantially Equivalent on Apr 19, 1985. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Medical Equipment Designs, Inc. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 19, 1985
- Date Received
- Apr 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type
- 510(k)