The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Collin Body Plethysmograph Plus System.
Device ID | K852102 |
510k Number | K852102 |
Device Name: | COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM |
Classification | Plethysmograph, Pressure |
Applicant | WARREN E. COLLINS, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
Contact | James Tully |
Correspondent | James Tully WARREN E. COLLINS, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
Product Code | CCM |
CFR Regulation Number | 868.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-15 |
Decision Date | 1985-07-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00852417003446 | K852102 | 000 |