MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP— 510(k) K894667

Name: FDA 510(k) clearance K894667
Creator: U.S. Food and Drug Administration
Published: 1989-10-19

Substantially Equivalent

Pneumedics, Inc.

FDA 510(k) clearance K894667 for MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP, Substantially Equivalent on 1989-10-19. Applicant: Pneumedics, Inc.. Device class: 2.

Clearance details

Applicant: Pneumedics, Inc.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1989-07-25
Decision date: 1989-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, US

Download summary PDF View on FDA.gov ↗

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