The following data is part of a premarket notification filed by Ametek, Inc. with the FDA for Carbon Dioxide Analyzer (model Cd-3a).
Device ID | K942113 |
510k Number | K942113 |
Device Name: | CARBON DIOXIDE ANALYZER (MODEL CD-3A) |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | AMETEK, INC. 150 FREEPORT RD. Pittsburgh, PA 15238 |
Contact | James B Gillikin |
Correspondent | James B Gillikin AMETEK, INC. 150 FREEPORT RD. Pittsburgh, PA 15238 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-02 |
Decision Date | 1995-02-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B9671502000 | K942113 | 000 |