510(k) K913396
K913396 is an FDA 510(k) premarket notification submitted by Pro-Tech, Inc. for the device "CANNULA STYLE THERMOCOUPLES". The FDA issued a decision of Substantially Equivalent on May 22, 1992. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Pro-Tech, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 1992
- Date Received
- Jul 30, 1991
- 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)