The following data is part of a premarket notification filed by Pneupac, Inc. with the FDA for Babypac.
Device ID | K970158 |
510k Number | K970158 |
Device Name: | BABYPAC |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PNEUPAC, INC. P.O. BOX 973 Wake Forest, NC 27588 |
Contact | Norman Gray |
Correspondent | Norman Gray PNEUPAC, INC. P.O. BOX 973 Wake Forest, NC 27588 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-16 |
Decision Date | 1998-04-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30610586045749 | K970158 | 000 |
30610586038284 | K970158 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BABYPAC 90244639 not registered Live/Pending |
LAR Digital Logistics 2020-10-09 |
![]() BABYPAC 75074325 not registered Dead/Abandoned |
Advantex Marketing International Inc. 1996-03-18 |
![]() BABYPAC 74272975 not registered Dead/Abandoned |
ADVANTEX MARKETING INTERNATIONAL INC. 1992-05-06 |