510(k) K810340
K810340 is an FDA 510(k) premarket notification submitted by Todd Industries, Inc. for the device "ADULT MASKS & PEDIATRIC MASKS". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Todd Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1981
- Date Received
- February 10, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5580
- Review Panel
- AN
- Submission Type