PACER SENSING ANALYZER (PSA 100)

FDA 510(k) Premarket Notification · Submission K882327 · Applicant: Oscor Medical Corp.

Public Record 510(k) Submission Decision Date: 1988-10-06 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K882327.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K882327

Applicant / Sponsor

Oscor Medical Corp.

Device Name

PACER SENSING ANALYZER (PSA 100)

Product Code

DTC

Decision Date

1988-10-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

1988-06-06

Related Establishments / Registrations

BIOTRONIK, INC. Registration: 1028232 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
MEDTRONIC, INC. Registration: 2182208 View Registration
NETECH CORP. Registration: 2436826 View Registration
AMPHENOL ALDEN PRODUCTS COMPANY Registration: 3012260771 View Registration
BIOTRONIK SE & CO. KG Registration: 9610139 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.