510(k) K884149
K884149 is an FDA 510(k) premarket notification submitted by Comfort Strap Co. for the device "COMFORT STRAP". The FDA issued a decision of Substantially Equivalent on October 21, 1988. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1988
- Date Received
- October 3, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Nasal, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5340
- Review Panel
- AN
- Submission Type