ABN ANEROID SPHYGMOMANOMETER

Blood Pressure Cuff

PT. SUGIH INSTRUMENDO ABADI

The following data is part of a premarket notification filed by Pt. Sugih Instrumendo Abadi with the FDA for Abn Aneroid Sphygmomanometer.

Pre-market Notification Details

• Device ID: K012444
• 510k Number: K012444
• Device Name: ABN ANEROID SPHYGMOMANOMETER
• Classification: Blood Pressure Cuff
• Applicant: PT. SUGIH INSTRUMENDO ABADI 933A MOTOR PKWY. Hauppauge, NY 11788
• Contact: Richard Graver
• Correspondent: Pat Paladino; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: DXQ
• CFR Regulation Number: 870.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2001-08-01
• Decision Date: 2001-08-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00697077000639	K012444	000
00697077000493	K012444	000
00697077000486	K012444	000
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