OPTI CCA-TS2

Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

OPTI MEDICAL SYSTEMS INC.

The following data is part of a premarket notification filed by Opti Medical Systems Inc. with the FDA for Opti Cca-ts2.

Pre-market Notification Details

• Device ID: K131126
• 510k Number: K131126
• Device Name: OPTI CCA-TS2
• Classification: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
• Applicant: OPTI MEDICAL SYSTEMS INC. 235 Hembree Park Dr Roswell, GA 30076
• Contact: Len Owens
• Correspondent: Len Owens; OPTI MEDICAL SYSTEMS INC. 235 Hembree Park Dr Roswell, GA 30076
• Product Code: CHL
• Subsequent Product Code: CDS
• Subsequent Product Code: CEM
• Subsequent Product Code: CGA
• Subsequent Product Code: CGZ
• Subsequent Product Code: GKR
• Subsequent Product Code: GLY
• Subsequent Product Code: JFP
• Subsequent Product Code: JGS
• Subsequent Product Code: KHP
• CFR Regulation Number: 862.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-04-22
• Decision Date: 2013-08-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00894472000275	K131126	000
00894472000268	K131126	000
00894472000251	K131126	000