510(k) K944512
K944512 is an FDA 510(k) premarket notification submitted by Monaghan Medical Corp. for the device "TRUZONE PFM DISPOSABLE MOUTHPIECE". The FDA issued a decision of Substantially Equivalent on November 2, 1994. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Monaghan Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 1994
- Date Received
- September 15, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthpiece, Breathing
- Device Class
- Class I
- Regulation Number
- 868.5620
- Review Panel
- AN
- Submission Type