510(k) K832418
K832418 is an FDA 510(k) premarket notification submitted by Airco/Ohio Medical Products for the device "OHIO TEMPERATURE SIMULATOR". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Airco/Ohio Medical Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1983
- Date Received
- July 22, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal
- Device Class
- Class II
- Regulation Number
- 880.5400
- Review Panel
- HO
- Submission Type