The following data is part of a premarket notification filed by Pennwalt Corp. with the FDA for Portable Pneumatic Calibrator 65-150.
Device ID | K780981 |
510k Number | K780981 |
Device Name: | PORTABLE PNEUMATIC CALIBRATOR 65-150 |
Classification | Calibrator, Pressure, Gas |
Applicant | PENNWALT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BXX |
CFR Regulation Number | 868.2620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-14 |
Decision Date | 1978-08-02 |