510(k) K952844
K952844 is an FDA 510(k) premarket notification submitted by Gibeck, Inc. for the device "HUMID-VENT 2". The FDA issued a decision of Substantially Equivalent on July 20, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Gibeck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1995
- Date Received
- June 21, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condenser, Heat And Moisture (Artificial Nose)
- Device Class
- Class I
- Regulation Number
- 868.5375
- Review Panel
- AN
- Submission Type