The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Model 7-at Treatment Chamber.
Device ID | K896721 |
510k Number | K896721 |
Device Name: | MODEL 7-AT TREATMENT CHAMBER |
Classification | Chamber, Patient Isolation |
Applicant | J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
Contact | George P Emerson |
Correspondent | George P Emerson J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
Product Code | LGM |
CFR Regulation Number | 880.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-28 |
Decision Date | 1990-01-22 |