510(k) K791861
K791861 is an FDA 510(k) premarket notification submitted by Ann Arbor Plastics, Inc. for the device "OXYGEN HOODS". The FDA issued a decision of Substantially Equivalent on Oct 4, 1979. The device falls under product code FOG (Hood, Oxygen, Infant), a Class I device regulated under 21 CFR 868.5700. Ann Arbor Plastics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 4, 1979
- Date Received
- Sep 24, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hood, Oxygen, Infant
- Device Class
- Class I
- Regulation Number
- 868.5700
- Review Panel
- AN
- Submission Type