510(k) K885313
K885313 is an FDA 510(k) premarket notification submitted by Life Design Systems, Inc. for the device "HUMIDI-FLEX TM". The FDA issued a decision of Substantially Equivalent on October 11, 1989. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Life Design Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 1989
- Date Received
- December 29, 1988
- 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