510(k) K832946
K832946 is an FDA 510(k) premarket notification submitted by Dale Medical Products, Inc. for the device "DALE ENDOTRACHEAL TUBE HOLDER". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280. Dale Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 1983
- Date Received
- September 2, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Breathing Tube
- Device Class
- Class I
- Regulation Number
- 868.5280
- Review Panel
- AN
- Submission Type