KAI SPOT MODEL KMS 200— 510(k) K100773

Substantially Equivalent

Kai Medical, Inc.

FDA 510(k) clearance K100773 for KAI SPOT MODEL KMS 200, Substantially Equivalent on 2010-06-23. Applicant: Kai Medical, Inc.. Device class: 2.

Clearance details

Applicant: Kai Medical, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2010-03-18
Decision date: 2010-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Honolulu, HI, US

Download summary PDF View on FDA.gov ↗

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