The following data is part of a premarket notification filed by Collins Medical, Inc. with the FDA for Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400.
| Device ID | K011344 |
| 510k Number | K011344 |
| Device Name: | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | COLLINS MEDICAL, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan COLLINS MEDICAL, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Product Code | BZC |
| Subsequent Product Code | BZG |
| Subsequent Product Code | CCM |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-02 |
| Decision Date | 2002-05-17 |