510(k) K771510
K771510 is an FDA 510(k) premarket notification submitted by Isothermal Systems, Inc. for the device "SERVO-PAK MOLEL 0030". The FDA issued a decision of Substantially Equivalent on August 16, 1977. The device falls under product code BXA (Analyzer, Gas, Water Vapor, Gaseous-Phase), a Class I device regulated under 21 CFR 868.1975. Isothermal Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1977
- Date Received
- August 5, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Water Vapor, Gaseous-Phase
- Device Class
- Class I
- Regulation Number
- 868.1975
- Review Panel
- AN
- Submission Type