The following data is part of a premarket notification filed by Ametek, Inc. with the FDA for Gaseous Oxygen Analyzer (model S-3a) Modification.
Device ID | K943824 |
510k Number | K943824 |
Device Name: | GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | AMETEK, INC. 300 WILLIAM PITT WAY Pittsburgh, PA 15238 |
Contact | Joe Veltry |
Correspondent | Joe Veltry AMETEK, INC. 300 WILLIAM PITT WAY Pittsburgh, PA 15238 |
Product Code | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-02 |
Decision Date | 1996-11-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B9671501000 | K943824 | 000 |