PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR

Pulse-generator, Pacemaker, External

OSYPKA MEDICAL, INC.

The following data is part of a premarket notification filed by Osypka Medical, Inc. with the FDA for Pace 101/pace 101h, Model 3077 Ssi Temporary Pulse Generator.

Pre-market Notification Details

• Device ID: K033130
• 510k Number: K033130
• Device Name: PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
• Classification: Pulse-generator, Pacemaker, External
• Applicant: OSYPKA MEDICAL, INC. 7855 IVANHOE AVE. SUITE 226 La Jolla, CA 92037
• Contact: Markus J Osypka
• Correspondent: Markus J Osypka; OSYPKA MEDICAL, INC. 7855 IVANHOE AVE. SUITE 226 La Jolla, CA 92037
• Product Code: DTE
• CFR Regulation Number: 870.3600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-30
• Decision Date: 2003-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169382978	K033130	000
04260451441012	K033130	000
00836559008859	K033130	000
04260451441050	K033130	000