The following data is part of a premarket notification filed by Cardiopulmonary Technologies, Inc. with the FDA for Cpt, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, Cpt, Inc. Meteor Hand Held Respiratory Mechanics Mo.
| Device ID | K982487 |
| 510k Number | K982487 |
| Device Name: | CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | CARDIOPULMONARY TECHNOLOGIES, INC. W 260 N 9311 HIGHWAY 164 Colgate, WI 53017 -9600 |
| Contact | Mark S Storsved |
| Correspondent | Mark S Storsved CARDIOPULMONARY TECHNOLOGIES, INC. W 260 N 9311 HIGHWAY 164 Colgate, WI 53017 -9600 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-17 |
| Decision Date | 1998-10-14 |