510(k) K853848
K853848 is an FDA 510(k) premarket notification submitted by Medical Graphics Corp. for the device "RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR". The FDA issued a decision of Substantially Equivalent on December 5, 1985. The device falls under product code BXW (Calibrator, Volume, Gas), a Class I device regulated under 21 CFR 868.1870. Medical Graphics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1985
- Date Received
- September 16, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Volume, Gas
- Device Class
- Class I
- Regulation Number
- 868.1870
- Review Panel
- AN
- Submission Type