The following data is part of a premarket notification filed by Starboard Medical, Llc with the FDA for Disposable Temperature Probes / Sensors And Interconnect Instrument Cables.
Device ID | K111282 |
510k Number | K111282 |
Device Name: | DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES |
Classification | Thermometer, Electronic, Clinical |
Applicant | STARBOARD MEDICAL, LLC 22845 SAVI RANCH PKWY SUITE H Yorba Linda, CA 92887 |
Contact | Anthony Beran |
Correspondent | Anthony Beran STARBOARD MEDICAL, LLC 22845 SAVI RANCH PKWY SUITE H Yorba Linda, CA 92887 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-06 |
Decision Date | 2011-08-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10850933007105 | K111282 | 000 |
10850933007099 | K111282 | 000 |
10850933007082 | K111282 | 000 |
10897392002746 | K111282 | 000 |
10897392003095 | K111282 | 000 |
10897392003088 | K111282 | 000 |
10080196551644 | K111282 | 000 |