The following data is part of a premarket notification filed by Barton Medical Corp. with the FDA for Convertible I-series Positioning And Transfer Chair.
Device ID | K071793 |
510k Number | K071793 |
Device Name: | CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR |
Classification | Chair, Positioning, Electric |
Applicant | BARTON MEDICAL CORP. 5725 HWY 290 WEST, #103 Austin, TX 78735 -8701 |
Contact | Lawrence W Swol |
Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-07-02 |
Decision Date | 2007-08-03 |
Summary: | summary |