The following data is part of a premarket notification filed by Medical Marketing Concepts with the FDA for Manual Resuscitator With Ace.
| Device ID | K982215 |
| 510k Number | K982215 |
| Device Name: | MANUAL RESUSCITATOR WITH ACE |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | MEDICAL MARKETING CONCEPTS P.O. BOX 4341 Crofton, MD 21114 -4341 |
| Contact | E J Smith |
| Correspondent | E J Smith MEDICAL MARKETING CONCEPTS P.O. BOX 4341 Crofton, MD 21114 -4341 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-23 |
| Decision Date | 1998-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20889483111854 | K982215 | 000 |
| 20889483098124 | K982215 | 000 |
| 20889483097929 | K982215 | 000 |
| 20889483097905 | K982215 | 000 |
| 20889483097448 | K982215 | 000 |
| 20889483092030 | K982215 | 000 |
| 20889483084295 | K982215 | 000 |
| 30889483230644 | K982215 | 000 |
| 10889483172322 | K982215 | 000 |
| 10889483160497 | K982215 | 000 |
| 10889483107331 | K982215 | 000 |
| 20889483098667 | K982215 | 000 |
| 20889483098674 | K982215 | 000 |
| 20889483102708 | K982215 | 000 |
| 20889483111694 | K982215 | 000 |
| 20889483110444 | K982215 | 000 |
| 20889483110437 | K982215 | 000 |
| 20889483110048 | K982215 | 000 |
| 20889483109264 | K982215 | 000 |
| 20889483109257 | K982215 | 000 |
| 20889483105747 | K982215 | 000 |
| 20889483103545 | K982215 | 000 |
| 20889483103255 | K982215 | 000 |
| 20889483102937 | K982215 | 000 |
| 10889483086919 | K982215 | 000 |