510(k) K875075
K875075 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "RT-200 COMPUTER INTERFACE". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code BXX (Calibrator, Pressure, Gas), a Class I device regulated under 21 CFR 868.2620. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1988
- Date Received
- December 9, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Pressure, Gas
- Device Class
- Class I
- Regulation Number
- 868.2620
- Review Panel
- AN
- Submission Type