The following data is part of a premarket notification filed by P.k. Morgan Ltd. with the FDA for Benchmark Transfer Test.
Device ID | K954730 |
510k Number | K954730 |
Device Name: | BENCHMARK TRANSFER TEST |
Classification | Calculator, Pulmonary Function Data |
Applicant | P.K. MORGAN LTD. 4 BLOORS LANE Kent Rainham Me8 7ed, GB |
Contact | R. H Jkernaghan |
Correspondent | R. H Jkernaghan P.K. MORGAN LTD. 4 BLOORS LANE Kent Rainham Me8 7ed, GB |
Product Code | BZC |
CFR Regulation Number | 868.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-16 |
Decision Date | 1997-04-01 |