The following data is part of a premarket notification filed by Aci Medical, Inc. with the FDA for Air Plethysmograph Model Apg-1000.
| Device ID | K881291 |
| 510k Number | K881291 |
| Device Name: | AIR PLETHYSMOGRAPH MODEL APG-1000 |
| Classification | Plethysmograph, Impedance |
| Applicant | ACI MEDICAL, INC. 9249 GLENOAKS BL. Sun Valley, CA 91352 |
| Contact | Ed Arkans |
| Correspondent | Ed Arkans ACI MEDICAL, INC. 9249 GLENOAKS BL. Sun Valley, CA 91352 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-28 |
| Decision Date | 1988-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860446000312 | K881291 | 000 |