510(k) K921178
K921178 is an FDA 510(k) premarket notification submitted by Medical Associated Services, Inc. for the device "PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS". The FDA issued a decision of Substantially Equivalent on August 26, 1992. The device falls under product code JAX (Pneumotachometer), a Class II device regulated under 21 CFR 868.2550. Medical Associated Services, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1992
- Date Received
- March 9, 1992
- 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