510(k) K940013
K940013 is an FDA 510(k) premarket notification submitted by Pro-Tech, Inc. for the device "BODY POSITION INDICATOR, MODEL BPI1". The FDA issued a decision of Substantially Equivalent on May 4, 1995. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Pro-Tech, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 1995
- Date Received
- Jan 4, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type
- 510(k)