510(k) K833265
K833265 is an FDA 510(k) premarket notification submitted by Thoratec Laboratories Corp. for the device "RESPIRATORY FLOW MODULE". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code JAX (Pneumotachometer), a Class II device regulated under 21 CFR 868.2550. Thoratec Laboratories Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 1983
- Date Received
- September 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pneumotachometer
- Device Class
- Class II
- Regulation Number
- 868.2550
- Review Panel
- AN
- Submission Type