The following data is part of a premarket notification filed by Porter Instrument Co., Inc. with the FDA for Digital Mxr-d Flowmeter.
Device ID | K062155 |
510k Number | K062155 |
Device Name: | DIGITAL MXR-D FLOWMETER |
Classification | Gas-machine, Anesthesia |
Applicant | PORTER INSTRUMENT CO., INC. 49 PLAIN STREET North Attlrboro, MA 02760 |
Contact | Cynthia J.m. Nolte |
Correspondent | Cynthia J.m. Nolte PORTER INSTRUMENT CO., INC. 49 PLAIN STREET North Attlrboro, MA 02760 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-28 |
Decision Date | 2006-11-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816711020202 | K062155 | 000 |