The following data is part of a premarket notification filed by P.k. Morgan Ltd. with the FDA for Autolink Body Plethysmograph.
| Device ID | K960121 |
| 510k Number | K960121 |
| Device Name: | AUTOLINK BODY PLETHYSMOGRAPH |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | P.K. MORGAN LTD. 4 BLOORS LANE Kent Rainham Me8 7ed, GB |
| Contact | R.h. Kernaghan |
| Correspondent | R.h. Kernaghan 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 | 1996-01-11 |
| Decision Date | 1997-01-09 |